MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog 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 for expert nails/100mm (p/n: 03.010.486, lot #: 8865176) was returned and received at us cq.Upon visual inspection, it was observed that the distal tab of the insertion handle was broken.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the broken tab.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the radiolucent insertion handle for expert nails/100mm (p/n: 03.010.486, lot #: 8865176).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 # 8865176.Manufacturing site: (b)(4).Release to warehouse date: 25 apr 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that a radiolucent insertion handle for expert nails is faulty.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 report is for one (1) radiolucent insertion handle for expert nails/100mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12460532
• Report Number: 8030965-2021-07662
• Device Sequence Number: 14397691
• Product Code: LXH
• UDI-Device Identifier: 07611819498853
• UDI-Public: (01)07611819498853
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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 Catalogue Number: 03.010.486
• Device Lot Number: 8865176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1