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

Catalog Number	03.111.751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6), 2022, there was a chip in the resin material of the product at the time of inspection when the product was delivered to the hospital.This event occurred on the day before surgery, and the sales representative re-arranged the product.On (b)(6), 2022, the patient underwent open reduction internal fixation for fracture of the distal radius.The surgery was completed with no delay.Upon manufacturer investigation, it was determined that the device was broken.This report is for a soft tissue attchmt/j-shaped f/bone reduction forceps.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.Par: 03.111.751, lot: 102627.Manufacturing site: (b)(4).Release to warehouse date: november 03, 2020.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 soft tiss attach j-shap f/reduc forceps had a part of the connection feature broken.The fragment was returned for analysis.No other issues were identified during examination of the piece.A dimensional inspection for the soft tiss attach j-shap f/reduc forcepsand was unable to be performed due to post manufacturing damage.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 soft tiss attach j-shap f/reduc forceps 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.Drawing/specifications reviewed.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: soft tissue attachment j-shapped f/redu weichteilaufsatz j-forming f/repositionszange soft tissue bone reductions forceps.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
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14438145
• Report Number: 8030965-2022-03308
• Device Sequence Number: 5029272
• Product Code: HTD
• UDI-Device Identifier: 07611819597587
• UDI-Public: (01)07611819597587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 03.111.751
• Device Lot Number: 102627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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