MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION SLEEVE ATTACHMENT FOR 4.5MM HCS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.226.038
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition was confirmed, as it can be seen that the one of distal flanges is bent inward which will hinder the functionality.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the instrument was in poor condition and close to its definitive expiration date.The piece was not used intra-surgically but this issue was discovered after opening the sterile package.The tips of the anchor were deviated.This report is for one (1) compression sleeve attachment for 4.5mm hcs.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.H3, h6: a product investigation was conducted.Image review: the image(s) was reviewed, and the complaint condition was confirmed, as it can be seen that the one of distal flanges is bent inward which will hinder the functionality.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Visual inspection: the attach f/compress-sleeve f/hcs ø4.5 (p/n: 03.226.038, lot number: 2418870) was received at us cq.Upon visual inspection, the one of distal flanges is bent inward which will impact the functionality of the device.Additionally, scratches and fading etch were observed on the device.No other issues were identified with the returned device.Dimensional inspection: complaint relevant dimensional inspection could not be conducted due to post manufacturing damage and geometry of the device.Document/specification review: the relevant documents were reviewed: no design issues or discrepancies were identified.Investigation conclusion: this complaint could be confirmed as one of the distal flange on the returned device is bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.226.038, lot: 2418870, manufacturing site: bettlach, release to warehouse date: 26 nov 2008.Due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPRESSION SLEEVE ATTACHMENT FOR 4.5MM HCS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11863560
• Report Number: 2939274-2021-02492
• Device Sequence Number: 13727878
• Product Code: LXH
• UDI-Device Identifier: 07611819989566
• UDI-Public: 07611819989566
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.226.038
• Device Lot Number: 2418870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR