MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS

Catalog Number 03.111.751

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 soft tissue retractor broke on (b)(6) 2020 while trying to remove it from the forceps at the end of the case.Fragment was generated from broken device but it was easily removed without additional intervention as it broke once the operation was over.There was no surgical delay reported.Procedure was successfully completed.Patient outcome is as expected, and treatment proceeded as planned.No further information provided.Concomitant device reported: reduction forceps with ball tip (part # 03.111.750, lot # unknown, quantity 1).This report is for one (1) soft tissue attchmt/j-shaped f/bone reduction forceps.This is report 1 of 1 for complaint (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, h6: a product investigation was conducted.Visual inspection: the connection feature of the soft tissue attachment presents that the half support is completely broken off.The broken off part was also returned for investigation.The instrument presents normal signs of use.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint condition is confirmed as the half connection support is completely broken off.Although a definitive root cause for the breakage could not be determined, it is likely that this complaint condition was due to excessive force / strain during use or a improper handling during sterile processing.During the investigation, no product design or manufacturing issues were observed 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 as no product related issue could be detected.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.111.751, synthes lot number: 514970, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 11.Oct.2017.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10780805
• MDR Text Key: 214632306
• Report Number: 8030965-2020-08536
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819597587
• UDI-Public: (01)07611819597587
• 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: 10/08/2020

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: 03.111.751
• Device Lot Number: 514970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REDUC-FORC W/BALL TIPS