MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.486
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 sales representative.A product investigation was conducted.Visual inspection: the radiolucent insertion handle, l 100mm (p/n: 03.010.486, lot # 9482439) was received and received at us cq.Upon visual inspection, the broken tip of the mating driving cap was retained in the threaded portion of the insertion handle but could be fully removed.Also, it was observed that the distal tab of the insertion handle was broken.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection was not performed due to the post-manufacturing damage.Document/specification review: the relevant drawing reflecting the current and manufactured revision was reviewed: no design issues or discrepancies were identified.Investigation conclusion: the complaint condition was confirmed for the radiolucent insertion handle for expert nails/100mm (p/n: 03.010.486, lot #: 9482439).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.A device history record (dhr) review was conducted: part # 03.010.486, lot # 9482439, release to warehouse date: 22 jun 2015, manufacturer: (b)(4).No ncr's were generated during production.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 an unknown procedure the driving cap and handle were broken due to unknown reason.No further information provided.During manufacturer's investigation of the returned device it was identified that the distal tab of the insertion handle was broken.This device condition was evaluated and determined to be reportable on july 30, 2021.This report is for one (1) radiolucent insertion handle for expert nails/100mm.This is report 3 of 3 for complaint (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12304710
• Report Number: 2939274-2021-04589
• Device Sequence Number: 19793052
• Product Code: LXH
• UDI-Device Identifier: 10886982069047
• UDI-Public: (01)10886982069047
• Combination Product (Y/N): N
• 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): 06/14/2021

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: 03.010.486
• Device Catalogue Number: 03.010.486
• Device Lot Number: 9482439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1