UNKNOWN SUSPENSORY FIXATION DEVICE
Received Jan 11, 2023 · Event occurred Feb 13, 2022
Report 1219602-2023-00078 · MDR key 16139840
Device
Generic name
Retention Device, Suture
Manufacturer
Smith & Nephew, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Joint Laxity
- Joint Laxity
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON THE LITERATURE REVIEW "TENSIONING DEVICE INCREASES CORACOID BONE BLOCK HEALING RATES IN ARTHROSCOPIC LATARJET PROCEDURE WITH SUTURE-BUTTON FIXATION;" 1 PATIENT HAD A TRAUMATIC RECURRENT SHOULDER INSTABILITY AT A MEAN OF 7 MONTHS (RANGE, 5-12 MONTHS) AFTER AN ARTHROSCOPIC LATARJET PROCEDURE WHERE A SUTURE BUTTON AND TENSIONING DEVICE WERE USED (MECHANICALLY TENSIONED). THE PATIENT OUTCOME IS UNKNOWN, AND NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: (B)(4).
Additional Manufacturer Narrative
CORRECTED INFORMATION IN D1 (BRAND NAME).
Additional Manufacturer Narrative
A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS AN INSTRUCTION FOR USE REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A CLINICAL REVIEW STATES THAT THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE CLINICAL ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE LITERATURE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.