MAUDE Adverse Event Report: SYNTHES GMBH DHS®/DCS® ONE-STEP INSERTION WRENCH

Catalog Number	338.302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot, part: 338.302, lot: 8236363, manufacturing site: bettlach, release to warehouse date: 18 april 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the dhs/dcs wrench broke while inserting a screw into hard bone.The procedure was successfully completed.There is no further information available.This report is for one (1) dhs®/dcs® one-step insertion wrench.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: part: 338.302, lot: 8236363, manufacturing site: bettlach, release to warehouse date: april 18, 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device wrench with hexagonal coupling (product code: 338.302, lot number: 8236363) was returned to customer quality (cq) west chester for investigation.The tip of the wrench had broken off and the broken part was not returned for investigation.The device also had several scratches on its surface which did not contribute to the complaint condition.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Wrench with hexagonal coupling stem for wrench dimensional inspection: diameter: conforming measuring device used: caliper.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the tip of the wrench had been broken surgery and it was confirmed during investigation.A definitive root cause was not determined during investigation.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.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: DHS®/DCS® ONE-STEP INSERTION WRENCH
• Common Device Name: WRENCH
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12699229
• Report Number: 8030965-2021-08992
• Device Sequence Number: 4282013
• Product Code: HXC
• UDI-Device Identifier: 07611819203235
• UDI-Public: (01)07611819203235
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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
• Device Catalogue Number: 338.302
• Device Lot Number: 8236363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2013
• 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: CONNECSCR F/DHS/DCS-WRENCH NO. 338.300; UNK - SCREWS: DHS/DCS; CONNECSCR F/DHS/DCS-WRENCH NO. 338.300; UNK - SCREWS: DHS/DCS
• Patient Sex: Unknown