MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE REDUCTION FORCEPS-LARGE

Model Number	398.985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported is a j&j sales representative.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 or Problem Description
It was reported on (b)(6) 2020 that the bone reduction forceps-large has a broken tip.It was found during testing.There was no patient involvement.This complaint involves 1 device for bone reduction forceps-large.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.H3, h6: a product investigation was conducted.Visual inspection: the bone reduction forceps-large (p/n: 398.985, lot number: a7oa14) was received at us cq.Upon visual inspection, it was observed that the right jaw tip had broken off.No other defects were observed on the complaint device.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage and device geometry.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the right jaw tip had broken off.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.Part number: 398.985, lot number: a7oa14, manufacturing site: tuttlingen, release to warehouse date: week 14, 2005.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 15 years old).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: BONE REDUCTION FORCEPS-LARGE
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10030532
• Report Number: 2939274-2020-02269
• Device Sequence Number: 11609799
• Product Code: HTD
• UDI-Device Identifier: 10887587041810
• UDI-Public: (01)10887587041810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 398.985
• Device Catalogue Number: 398.985
• Device Lot Number: A70A14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1