MAUDE Adverse Event Report: STRYKER GMBH FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514213S
Medical Device Problem Codes	Off-Label Use (1494); Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2023
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
As reported: "the service&repair center in the netherlands reported a stryker drill bit found stuck in a depuy synthes attachment.The attachment isn't working properly; the customer didn't provide further information.¿.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned and found to be fully functional.Device inspection revealed the following: the received drill was visually inspected which shows clear deformation though out the drill cutting edges and tip have become blunt in nature, and the locking section is having material chipped off and bent inward which indicates forceful locking of the device.A functional test was performed with the sample drill machine in which we didn¿t find any issue in the assembly and disassembly of the device.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, the root cause was attributed to being an off-label use as the component was used with another manufacturer component, which is confirmed from the available pictures.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the service&repair center in the netherlands reported a stryker drill bit found stuck in a depuy synthes attachment.The attachment isn't working properly; the customer didn't provide further information.¿.

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM
• 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: 17470516
• Report Number: 0009610622-2023-00273
• Device Sequence Number: 15293034
• Product Code: LXH
• UDI-Device Identifier: 07613327350289
• UDI-Public: 07613327350289
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 23514213S
• Device Lot Number: KU151070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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
• Patient Sex: Unknown