UNKN JOINT REPAIR DEV

Description of Event or Problem

IT WAS REPORTED THAT ON LITERATURE REVIEW "SQUEAKING KNEE IS A RARE COMPLICATION OF ACL SURGERY", 1 PATIENTS HAD ¿SQUEAKING NOISE COMING FROM HER KNEE WITH FLEXION AND EXTENSION MOVEMENTS.¿ 8 MONTHS AFTER A "LEFT ACL RECONSTRUCTION" PROCEDURE USING ONE (1) XTENDOBUTTON DEVICE. THE EVENT WAS RESOLVED WITH A REVISION SURGERY THAT REMOVED SOME LOOSE FIBER LOOP SUTURE PROTRUDING THROUGH THE TIBIAL TUNNEL AND INTO THE MEDIAL COMPARTMENT. PATIENT SQUEAKING SOUND COMPLETELY RESOLVED AFTER THE SURGERY WITHOUT PAIN OR INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: H2: ADDITIONAL INFORMATION: B5, D4 AND H4. CORRECTED DATA: ATTACHMENTS.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: FRAZER, P. M., & TALBOT, W. (2022). A SQUEAKING KNEE IS A RARE COMPLICATION OF ACL SURGERY: A CASE REPORT. JBJS CASE CONNECTOR, 12(4), E22. H10: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT ON LITERATURE REVIEW "SQUEAKING KNEE IS A RARE COMPLICATION OF ACL SURGERY", 1 PATIENTS HAD ¿SQUEAKING NOISE COMING FROM HER KNEE WITH FLEXION AND EXTENSION MOVEMENTS.¿ 8 MONTHS AFTER A "LEFT ACL RECONSTRUCTION" PROCEDURE USING AN XTENDO BUTTON. THE EVENT WAS RESOLVED WITH A REVISION SURGERY THAT REMOVED SOME LOOSE FIBERLOOP SUTURE PROTRUDING THROUGH THE TIBIAL TUNNEL AND INTO THE MEDIAL COMPARTMENT. PATIENT SQUEAKING SOUND COMPLETELY RESOLVED AFTER THE SURGERY WITHOUT PAIN OR INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT BASED ON THE INFORMATION PROVIDED IN THE ARTICLE THE CLINICAL ROOT CAUSE OF THE KNEE SQUEAKING WAS CONCLUDED TO BE THE RESULT OF LOOSE SUTURES FROM A COMPETITOR AND NOT A MAL PERFORMANCE OF THE S&N DEVICES. PER ARTICLE, THE SQUEAKING SOUND WAS COMPLETELY RESOLVED FOLLOWING SURGERY WITH NO RECURRENCE. SINCE NO FURTHER HARM IS ANTICIPATED NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. BASED ON THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO CONCLUDE ON FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. INTERNAL COMPLAINT REFERENCE (B)(4). H6: ANNEX E AND F CODES UPDATED.