MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1006
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, metal abrasion occurred when connecting the strike plate and the nail handle.
Additional Manufacturer Narrative
Correction: sections d10, h3.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.Due to the current covid-19 pandemic, it was not possible to receive the product for evaluation.The investigation will be reassessed as soon as the product is received.The batch record could not be reviewed because the affected device was not returned, and the dhr could not be received.Dhrs were requested internally but could not be provided due to current pandemic restrictions.This is the first reported case with this lot number.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.Device return delayed due to covid-19 pandemic restrictions.
Event or Problem Description
It was reported, metal abrasion occurred when connecting the strike plate and the nail handle.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.However, one of the possible root causes could be: improper and incomplete insertion (only 2-3 windings) of the strike plate in the nail handle (not fully flush to the surface) which upon hammering lead to deformation of the threads due to overloading.If any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported, metal abrasion occurred when connecting the strike plate and the nail handle.

• Brand Name: NAIL HANDLE T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9891025
• Report Number: 0009610622-2020-00130
• Device Sequence Number: 10894281
• Product Code: LXH
• UDI-Device Identifier: 04546540196552
• UDI-Public: 04546540196552
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2020

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: 1806-1006
• Device Catalogue Number: 18061006
• Device Lot Number: KHI125711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/16/2020; 07/30/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/13/2020; 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR