MAUDE Adverse Event Report: STRYKER GMBH DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23513240S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
The k-wire drill broke during a surgery.New information received from the surgeon/company rep: everything was done by the book, but the k-wire was not in the desired position to place the recon screw.It was reinserted, but then it broke.Fortunately, a small piece was still protruding from the bone, allowing us to remove the wire, though it was not a quick and easy process.The patient was a 76-year-old woman operated on under general anesthesia.
Additional Manufacturer Narrative
Correction: please refer to h6 (method code , result code, conclusion code, clinical code, component code), d4 - lot #, d9 - product available to stryker, h3 - device evaluated by mfg.The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The device was received broken into two fragments from the shaft.We can also see rubbing marks around the complete shaft of the which reflects that device rubbed with the corresponding device.Microscopic view of the device indicates towards a plastic deformation around the center of shaft caused by application of high torsional and axial load.The force led to deformation causing the breakage in the ductile manner.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation root cause can be attributed to user-related as the device shows signs of application of excessive force causing deformation and leading to breakage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The k-wire drill broke during a surgery.New information received from the surgeon/company rep: everything was done by the book, but the k-wire was not in the desired position to place the recon screw.It was reinserted, but then it broke.Fortunately, a small piece was still protruding from the bone, allowing us to remove the wire, though it was not a quick and easy process.The patient was a 76-year-old woman operated on under general anesthesia.

• Brand Name: DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20073895
• Report Number: 0009610622-2024-00815
• Device Sequence Number: 17748299
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: 07613327361698
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23513240S
• Device Lot Number: KU163756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 10/12/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female