MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, STERILE T2 Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "42-year-old polytraumatized patient, victim of a road accident on (b)(6) 2024, treated for osteosynthesis of the right femur by closed-focus centromedullary nailing; during the operation, the drill bit broke.After checking with the image intensifier, the tip of the broken drill bit could be located and removed from the patient in its entirety.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the received drill bit is broken as reported.The device inspection revealed the following: the visual inspection has shown that the drill bit forefront with the cutting flutes is broken off at the crossover to the shaft.The microscopic inspection shows that the breakage surface reveals typical characteristics of a brittle fracture (relatively smoother surface at the center than at the edges).No material deformation can be observed.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mechanical overload during drilling, for example by an excessive contact with the nail during the preparation of a locking screw hole.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
The customer reported that "42-year-old polytraumatized patient, victim of a road accident on (b)(6) 2024, treated for osteosynthesis of the right femur by closed-focus centromedullary nailing; during the operation, the drill bit broke.After checking with the image intensifier, the tip of the broken drill bit could be located and removed from the patient in its entirety.".

• Brand Name: DRILL, AO, STERILE T2 Ø4,2X340 MM
• 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: 19159498
• Report Number: 0009610622-2024-00163
• Device Sequence Number: 7861902
• Product Code: LXH
• UDI-Device Identifier: 04546540196774
• UDI-Public: 04546540196774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 18064260S
• Device Lot Number: KU167984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Unknown