UNK RESECTION BLOCK

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - ACCORDING TO THE INFORMATION RECEIVED: "SEE THE ATTACHED PICTURE. IT SEEMS LIKE THE TWO SMALL DISTAL HOLES ON THE TIBIAL PIN BLOCKS ARE GETTING MANUFACTURED A LOT SMALLER THESE DAYS. THE SCRUB TECHS ARE HAVING ISSUES ATTACHING THE 2 PRONGED ATTACHMENT PIECE TO IT BECAUSE THE HOLES ARE A LOT SMALLER. IT HAS CREATED A FEW ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. WE¿VE ALSO HAD A COUPLE OF BLOCKS BREAK AT THAT JUNCTURE AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH. HAS THIS BEEN AN ISSUE FOR ANYONE ELSE? JUST WANTED TO PASS THIS ALONG AND ALSO ASK IF THIS IS A NEW DESIGN OR WHAT?". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENTS (EXTERNAL TIBIA BLOCK ISSUE.MSG AND 163844.MOV). THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT - A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED ADDED: D1.

Description of Event or Problem

IT WAS REPORTED THAT THE SCRUB TECHS WERE HAVING ISSUES ATTACHING THE 2-PRONGED ATTACHMENT PIECE TO THE TIBIAL PIN BLOCKS BECAUSE THE HOLES SEEM TO BE MANUFACTURED SMALLER THAN PREVIOUSLY. IT HAS ALSO CREATED ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. A COUPLE OF BLOCKS HAVE BROKEN AT THAT JUNCTURE, AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.