MAUDE Adverse Event Report: SYNTHES GMBH RED FORCEPS POINTS NARROW-RATCHET 132

Catalog Number	398.40
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, one device has a bent tip and the other is not clamping correctly.It was unknown when the event occurred.There was no patient involvement.This report is for one red forceps points narrow-ratchet 132.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.H11 additional narrative: b3: unknown event date.E1: initial reporter is j&j company representative.H3, h4, h6 investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the weld of the closing screw was broken.This condition leads to a loosening of the ratcheting mechanism; therefore, the reported condition can be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like improper handling, excessive force during use, or accidental impact.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional evaluation was performed and found ratcheting mechanism was loose.The overall complaint was confirmed as the observed condition of the red forceps points narrow-ratchet 132 was contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to a component faiulre, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history: part number: 398.40.Lot number: 132p409 (wo# 17659041, 17659044, 17659049, 17659065, 17659249).Manufacturing site: tuttlingen, release to warehouse date: 12-jul-2021 (wo# 17659041), 13-jul-2021 (wo# 17659044, 17659049), 14-jul-2021 (wo# 17659065), 15-jul-2021 (wo# 17659249).A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: RED FORCEPS POINTS NARROW-RATCHET 132
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20129337
• Report Number: 8030965-2024-10624
• Device Sequence Number: 7399211
• Product Code: HTD
• UDI-Device Identifier: 10886982201355
• UDI-Public: (01)10886982201355(11)210712(17)411231(10)132P409
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,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: 398.40
• Device Lot Number: 132P409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown