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

Catalog Number	23514213S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported: "2 drill bits broke during a femoral nail procedure.The pieces of drill bit remained in the patient without consequence.".
Event or Problem Description
The customer reported: "2 drill bits broke during a femoral nail procedure.The pieces of drill bit remained in the patient without consequence.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: received drills found broken from the starting point of the cutting flutes.Both the drills show similar failure characteristics.Both the drills having round scratch marks on its periphery near the breakage point.Microscopic view of the broken surface indicates that the breakage is brittle in nature as evidenced by the appearance of flat portion connecting cutting flutes.This is due to excess contact with bone or wire resulting in the application of excessive torsional / bending load.Deformation at the corners of tip is because the surgeon most likely kept using the broken drill, without noticing that it was already broken.Due to this, the broken drill had excess contact with the bone or the drill guide or the broken fragment of the drill itself and resulted in this kind of deformation.Outer diameter of the drill was found within specification.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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 caused by application of excess bending and torsional force.If more information is provided, the case will be reassessed.

• 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: 19477289
• Report Number: 0009610622-2024-00266
• Device Sequence Number: 19816160
• Product Code: LXH
• UDI-Device Identifier: 07613327350289
• UDI-Public: 07613327350289
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 23514213S
• Device Lot Number: K1A2653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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