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

Model Number	03.010.486
Medical Device Problem Codes	Device Handling Problem (3265); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device received.A review of the device history record has been requested.Device history lot: part: 03.010.486-us, lot: 8474746, manufacturing site: hägendorf, release to warehouse date: 18.Sept.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Investigation summary background: it was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the radiolucent insertion handle for expert nail and driving cap/threaded were stuck together.There was no patient or hospital involvement.This complaint involves two (2) devices.Investigation flow: damage / device interaction / functional.Visual inspection: radiolucent insertion handle for expert nails/100mm (pn 03.010.486 ln 8474746) was received at us cq.Upon visual inspection at cq, it is observed that the broken threaded tip of the driving cap/threaded (pn 03.010.523 ln 8836145) was stuck in insertion handle.The remaining portions of the device shows normal wear consistent with the use.The complaint condition of unable to disassemble can not be confirmed.Functional test: a functional test could not be performed as the threaded tip was stuck inside the insertion handle.The allegation of inability to disassemble cannot be replicated at us cq.No, the allegation of inability to disassemble cannot be replicated at us cq.The mating device was noted to be broken.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.The broken threaded tip of the driving cap/threaded (03.010.523) was stuck in insertion handle and unable to disassemble, thus confirming the complaint.While a definitive root cause could not be identified, it is possible that an off-axis strike on the driving cap connected to insertion handle contributed to the complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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 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 routine incoming inspection of a loaner set, it was observed that the radiolucent insertion handle for expert nail and driving cap/threaded were stuck together.There was no patient or hospital involvement.This complaint involves two (2) devices.This report is for one (1) radiolucent insertion handle for expert nails/100mm.This report is 1 of 2 for (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM
• Common Device Name: MISC, SURGICAL, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9549187
• Report Number: 2939274-2020-00044
• Device Sequence Number: 16746149
• Product Code: LXH
• UDI-Device Identifier: 10886982069047
• UDI-Public: (01)10886982069047
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: 8474746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1