MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM

Model Number	03.605.001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.Investigation summary: visual inspection: disc rongeur straight without teeth 4mm (part number: 03.605.001 lot number: t945569, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the teeth of the rongeur had broken off.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Device failure / defect identified? yes.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to post manufacturing damage.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for disc rongeur straight without teeth 4mm (part number: 03.605.001 lot number: t945569, qty# 1) while a definitive root cause could not be identified for the reported problem, it is possible that the handle of the device might have encountered unintended forces.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 upon these results, 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 history lot.Part number: 03.605.001.Lot number: t945569.Manufacturing site: (b)(4).Release to warehouse date: 15-apr-2010.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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of the loaner set, it was observed that the disc rongeur straight without teeth was broken.There was no patient involvement.This report is for one (1) disc rongeur straight without teeth 4mm.This is report 1 of 1 for (b)(4).

• Brand Name: DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM
• Common Device Name: RONGEUR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11649666
• Report Number: 2939274-2021-01802
• Device Sequence Number: 14350374
• Product Code: HTX
• UDI-Device Identifier: 10705034712338
• UDI-Public: 10705034712338
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 03.605.001
• Device Catalogue Number: 03.605.001
• Device Lot Number: T945569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1