MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - FREEHAND DRILL D4.2X185MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514218S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported: "4.2x185mm drill bit broke off in our t2 alpha retrograde nail the drill bit hit the nail.We did not have perfect circles when the surgeon tried to drill through the hole.A 12x340 retrograde nail was used.A 4.2x130 drill was opened after the 185 broke.A 5x40mm screw was inserted in the hole above the one with the broke drill bit in it.The broken drill bit (one piece) is still in the hole of the nail.It is in the canal of the femur and not sticking out of either cortex.It could not be retrieved intraoperatively".
Event or Problem Description
It was reported: "4.2x185mm drill bit broke off in our t2 alpha retrograde nail the drill bit hit the nail.We did not have perfect circles when the surgeon tried to drill through the hole.A 12x340 retrograde nail was used.A 4.2x130 drill was opened after the 185 broke.A 5x40mm screw was inserted in the hole above the one with the broke drill bit in it.The broken drill bit (one piece) is still in the hole of the nail.It is in the canal of the femur and not sticking out of either cortex.It could not be retrieved intraoperatively".
Additional Manufacturer Narrative
Correction - please refer to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.However, it was reported that the drill bit had hit the nail, which most likely contributed to its breakage.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 investigation, the root cause was attributed to a user related issue.The event was most probably caused by the drill hitting the nail before its breakage.In this relation, the instructions for use state the following: avoid drilling into metal implants with bone drills.The implants could be critically weakened and break under load and the drill could be damaged.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN INSTRUMENTS - FREEHAND DRILL D4.2X185MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22862507
• Report Number: 0008031020-2025-01404
• Device Sequence Number: 7622848
• Product Code: LXH
• UDI-Device Identifier: 07613327350319
• UDI-Public: (01)07613327350319(17)350430(10)K12BB20
• Combination Product (Y/N): N
• 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): 11/19/2025

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: 23514218S
• Device Lot Number: K12BB20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 98 KG