MAUDE Adverse Event Report: SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

Catalog Number	03.019.025
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
Event or Problem Description
It was reported that on an unknown date in 2023 while inspecting trays in metro, it was noticed that the items in question were damaged.The procedure and patient outcome are not known.No further information is available to report.This report is for a scrwdrvr f/4.5mm ti multiloc screws/slf-retain/330mm.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: event occurred on an unknown date in 2023.E3: initial reporter is a synthes employee.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 03.019.025.Lot: l390587.Manufacturing site: werk hagendorf.Supplier: na.Release to warehouse date: 07 jun 2017.Expiration date: na.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that scrwdrvr 4.5 ti multilc scrs/slf-ret/330 was found broken from the head of the locking core, the broken fragment was returned for examination.The observed condition of the device was consistent with random component failure that may have been caused by exposure to unintended forces.No other issues were found.A dimensional inspection was not performed as it not applicable to the complaint condition.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 scrwdrvr 4.5 ti multilc scrs/slf-ret/330 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.

• Brand Name: SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17871271
• Report Number: 8030965-2023-12569
• Device Sequence Number: 5953909
• Product Code: HXX
• UDI-Device Identifier: 10886982069641
• UDI-Public: (01)10886982069641
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: 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: 03.019.025
• Device Lot Number: L390587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE WITH QUICK COUPLING, SMALL.; SDDRIVE(TM) SCREWDRIVER T15.
• Patient Sex: Unknown