MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REDUCTION INSTRUMENT T2 KIDS SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0193-3200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
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: today we were doing a femoral nail on a (b)(6) year old male at (b)(6) the surgeon was having a difficult time reducing the femur so we grabbed the ¿f tool¿ ((b)(4)) to help with reduction.She had to apply a fair amount of force to reduce the femur back together and as a result, one of the black pieces that connects to the larger rod broke right around the base of the threads.We were able to find a substitute tool and continue with the case.
Additional Manufacturer Narrative
Correction: refer to d4 lot number.The reported event that reduction instrument t2 kids small was alleged of issue ¿instrument - breakage during implantation¿ could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The above mentioned reduction instrument small consists of 3 components ¿ the metal reduction rod and two (carbon) radiolucent rods.The catalogue number of the rods is only used during manufacturing and is therefore not engraved on the devices.As per the visual inspection, one of the received carbon radiolucent rods was found to be significantly damaged around the thread undercut.The threads of the rod remained in the reduction instrument, the rest of the carbon rod remained undamaged and it simply snapped off near thread undercut.The breakage surface showed the typical structure of a forced fracture due to overload.No further visible damage was found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above facts and with the help of additional information received, it could be ascertained that the root cause is user related and specifically forced fracture due to overload on the carbon rod during reduction.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: today we were doing a femoral nail on a 13 year old male at (b)(6) hospital in (b)(6).The surgeon was having a difficult time reducing the femur so we grabbed the ¿f tool¿ (0193-3200) to help with reduction.She had to apply a fair amount of force to reduce the femur back together and as a result, one of the black pieces that connects to the larger rod broke right around the base of the threads.We were able to find a substitute tool and continue with the case.

• Brand Name: REDUCTION INSTRUMENT T2 KIDS SMALL
• 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: 10035134
• Report Number: 0009610622-2020-00189
• Device Sequence Number: 11416659
• Product Code: LXH
• UDI-Device Identifier: 04546540678522
• UDI-Public: 04546540678522
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 0193-3200
• Device Catalogue Number: 01933200
• Device Lot Number: K07294D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 59