MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE FOR LARGE LOCKING & VA SCREWS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	314.281
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply.H10 additional narrative: b3: only event year is known.E1 initial reporter address line 1: (b)(6).E3: reporter is a j&j employee.H3, h4, h6: product code: 314.281.Lot number: 22p3667.Manufacturing site: (b)(6).Release to warehouse date:(b)(6) 2020.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Visual analysis of the returned sample revealed that the guide shaft (part number: 507899) of the hold-sl f/scr f/lcp 4.5/5 was missing.No other issue was identified.A dimensional inspection for the hold-sl f/scr f/lcp 4.5/5 was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the hold-sl f/scr f/lcp 4.5/5 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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 synthes reports an event in portugal as follows: it was reported that during inspection at local distribution center it was identified that the device is damaged.During manufacturer's investigation of the returned device it was identified that the guide shaft was missing.This report is for one (1) holding sleeve for large locking & va screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HOLDING SLEEVE FOR LARGE LOCKING & VA SCREWS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16844739
• Report Number: 8030965-2023-05474
• Device Sequence Number: 6823221
• Product Code: LXH
• UDI-Device Identifier: 07611819248496
• UDI-Public: 07611819248496
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 314.281
• Device Lot Number: 22P3667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown