MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Model Number	03.008.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2021.Reporter is a j&j employee.Investigation summary: visual inspection: spiral blade inserter for hindfoot arthrodesis nail-ex (part # 03.008.011, lot # 1853725, qty#) was returned and received at us cq.Upon visual inspection at cq, it is observed that the inserter top was loose and falling apart from the assembly and there were several dents on the inserter top component.The handle part shows few scratches and nicks on the handle.Rest of the device shows normal wear which would not contribute to the complaint condition.No broken features were observed with the returned device.Device failure/defect identified? yes.Functional test: functional testing of the received device was performed at cq.The plunger of the inserter top was tight and not working as intended which caused the inserter top to fell apart.Dimensional inspection: dimensional inspection of the received device was not performed at cq as the internal components were inaccessible without the destruction of the device.Document/specification review the following drawing(s) was reviewed: spiral blade inserter, inserter top, spiral blade.No design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for spiral blade inserter for hindfoot arthrodesis nail-ex (part # 03.008.011, lot # 1853725) as no broken features were observed with the returned device.While a definitive root cause could not be identified for the reported problem, it is possible that the repeated use and service might have contributed to the complaint condition.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: 03.008.011, lot: 1853725, manufacturing site: (b)(4), release to warehouse date: april 11, 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 a loaner set, it was observed that spiral blade inserter was broken.There was no known patient or hospital involvement.This report is for one (1) spiral blade inserter for hindfoot arthrodesis nail-ex.This is report 1 of 1 for (b)(4).

• Brand Name: SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11405698
• Report Number: 2939274-2021-01137
• Device Sequence Number: 17276152
• Product Code: FZX
• UDI-Device Identifier: 10886982066909
• UDI-Public: 10886982066909
• 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
• 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): 02/08/2021

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: 03.008.011
• Device Catalogue Number: 03.008.011
• Device Lot Number: 1853725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1