MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING FORCEPS FOR TIBIAL EDGE FRAGMENTS 210MM

Model Number 399.16

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Part 399.16, lot 5800391: manufacturing site: salzburg.Release to warehouse date: june 26, 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection it was noticed that the cone component on the forceps was broken.No other defects were identified on the device.No dimensional analysis was performed due to confirmed post manufacturing damage identified.The drawings from the time of manufacture and current were reviewed.This complaint is not confirmed as one of the three cone component of the forceps was observed broken not bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.

Event Description

It was reported that on an unknown date, the holding forceps for tibial edge fragments was discovered bent.There was no patient involvement.During investigation by the manufacturer, it was noted that the cone component on the forceps was broken.This report is for a holding forceps.This is report 1 of 1 (b)(4).

• Brand Name: HOLDING FORCEPS FOR TIBIAL EDGE FRAGMENTS 210MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; 1020 WIEN; AS 1020 WIEN
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10959563
• MDR Text Key: 220175244
• Report Number: 2939274-2020-05472
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982202468
• UDI-Public: (01)10886982202468
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2020

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 Model Number: 399.16
• Device Catalogue Number: 399.16
• Device Lot Number: 5800391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2008
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1