MAUDE Adverse Event Report: STRYKER GMBH FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM; 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	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a single use drill bit snapped during a case.The drill snapped most likely not being fully straight through the locking hole.It was the proximal hole in a retrograde nail in quite a large leg so can be more tricky than the distal locking in a antegrade nail.It was through to the near cortex and the nail but just snapped when i was trying to go through the far cortex.It was completely flush in the bone and no way its going to come out or cause any issue.Update 01/mar/24: ¿ we used another drill (short one) and all fine no concerns problem was not 100% at 90 degrees to the hole and it snapped the drill.The patient was very large at the thigh and needed to the long drill to get to bone.Second locker down with short drill no problem.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the provided pictures show the broken drill bit remaining into the patient.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, it is possible that an angulation issue during drilling did contribute to the event.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that a single use drill bit snapped during a case.The drill snapped most likely not being fully straight through the locking hole.It was the proximal hole in a retrograde nail in quite a large leg so can be more tricky than the distal locking in a antegrade nail.It was through to the near cortext and the nail but just snapped when i was trying to go through the far cortex.It was completely flush in the bone and no way its going to come out or cause any issue.Update 01/mar/24: we used another drill (short one) and all fine no concerns problem was not 100% at 90 degrees to the hole and it snapped the drill.The patient was very large at the thigh and needed to the long drill to get to bone.Second locker down with short drill no problem.

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18960541
• Report Number: 0009610622-2024-00107
• Device Sequence Number: 20840791
• Product Code: LXH
• UDI-Device Identifier: 07613327350319
• UDI-Public: 07613327350319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 23514218S
• Device Lot Number: K199C12
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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 Sex: Unknown