MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE/ROD CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number	391.990
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part number: 391.990.Lot number: t936433.Manufacturing site: tuttlingen.Release to warehouse date: may 27, 2009.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.The instrument was received at us customer quality (cq) and upon inspection it can be seen that one of the three pivot screws is missing, an indication that the laser weld had failed/broke; resulting in the complaint description.No other issues were identified.A device failure was identified.Dimensional inspection: a dimensional inspection was done due to post manufacturing damage.Document/specification review: the following drawings were reviewed: plate cutter.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown, most likely that the laser dot was broken by excessive load on the screw by use of the device.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 or Problem Description
It was reported that on an unknown date, the plate/rod cutter did not function during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.During manufacturer's investigation of the returned device, it was identified that one of the three pivot screws is missing on the plate/rod cutter.This product condition was reassessed and determined as reportable on march 27, 2020.This report involves one (1) plate/rod cutter.This is report 1 of 1 for (b)(4).

• Brand Name: PLATE/ROD CUTTER
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9979005
• Report Number: 2939274-2020-01932
• Device Sequence Number: 16968091
• Product Code: HTZ
• UDI-Device Identifier: 10887587041087
• UDI-Public: (01)10887587041087
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 391.990
• Device Catalogue Number: 391.990
• Device Lot Number: T936433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1