MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STEPDRILL FOR LAG SCREW T2 RECON; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported: during femoral intramedullary nail surgery the top of stepdrill for lag screw was fracture.Surgeon tried different ways to remove broken piece.Finally, operation was failure.The broken piece remained in patient body.As operative plan, there two screws should implant.Because, the broken piece took screw position.Finally, only one screw implanted.
Event or Problem Description
It was reported: during femoral intramedullary nail surgery the top of stepdrill for lag screwv was fracture.Surgeon tried different ways to remove broken piece.Finally, operation was failure.The broken piece remained in patient body.As operative plan, there two screws should implant.Because, the broken piece took screw position.Finally, only one screw implanted.
Additional Manufacturer Narrative
The reported event could be confirmed.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).Step drill breakage during drilling is rarely known.The appearance of the breakage area of the returned step drill identified continued rotational force on the fragments after breakage, indication the step drill had already broken at an earlier position than presented on received x-ray.It was concluded the step drill interfered with the drill hole of the nail which requires significant deviation between target device / sleeve and the nail¿s drill hole.It is possible insufficient tightened nail holding screw, k-wire initially deflected or significant manual load on the targeting construct during drilling which would be regarded as user related.The use of a k-wire ¿ specifically when using a cannulated step drill ¿ is highlighted in the labelling.Thus, the root cause was regarded being user related.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.

• Brand Name: STEPDRILL FOR LAG SCREW T2 RECON
• 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: 9684864
• Report Number: 0009610622-2020-00046
• Device Sequence Number: 19521961
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 1806-3025
• Device Catalogue Number: 18063025
• Device Lot Number: KU93569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 52