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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.010.486, lot: l929371.Manufacturing site: (b)(4).Release to warehouse date: december 13, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the received image(s).The image(s) was reviewed, and the complaint condition was not confirmed since the complaint device had not broken.However, the broken tip of the driving cap was contained within the complaint device.There were also scratches and nicks on the complaint device.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 during inspection on an unknown date, broken equipment was discovered in the warehouse.There was no patient involvement.This report is for a radiolucent insertion handle for expert nails/100mm.This is report 1 of 2 for (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: 11744662
• Report Number: 2939274-2021-02142
• Device Sequence Number: 11787688
• 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): 04/05/2021

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: L929371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1