MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS/DCS COUPLING SCREW; EXTRACTOR

Catalog Number 338.31

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number, the device history records review could not be completed.Product was not returned.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 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the dhs coupling screw broke while inserting a dhs lag screw intraoperatively.No further information provided.Concomitant devices reported: unknown dhs lag screw (part# unknown, lot# unknown, quantity 1); dhs/dcs wrench (part# 338.300, lot# unknown, quantity 1).This report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 1 for (b)(4).

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, h4, h6: product code: 338.310, lot: l390608, manufacturing site: hägendorf, release to warehouse date: june 06, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection observed that the threaded tip section at the distal end of the shaft is broken off.The broken part is missing.The instrument shows wear marks and scratches on the surface at the distal section.At the head section, on the knurled part, are slightly damages visible as well the shaft is bent.The observed damage is consistent with the reported complaint condition; as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: feature: inner bore diameter result: pass feature: outer diameter (near breakage point) result: pass drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The broken sub-component 50101706 is not lot tracked.Therefore the last three potential work orders that were produced prior to lot l390608 were reviewed.The review has shown that the correct material was used.Investigation summary: our investigation has shown that the complaint condition for the received instrument is confirmed due to the breakage.The complaint relevant dimensions were checked as far as possible and found to be within specifications.This, and the findings above, let us exclude a manufacturing related issue.Based on the provided information, we are not able to determine the exact cause of this breakage.We do suppose that the device encountered unintended forces, such as use related excessive force application during its use, which finally resulted in the breakage of the tip.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 as no product related issue could be detected.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 COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10824355
• MDR Text Key: 216002401
• Report Number: 8030965-2020-08866
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819022133
• UDI-Public: (01)07611819022133
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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 Operator: Health Professional
• Device Catalogue Number: 338.31
• Device Lot Number: L390608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DHS/DCS-WRENCH F/ONE-STEP INSERT-TECHN; DHS/DCS-WRENCH F/ONE-STEP INSERT-TECHN; UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW; UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW