MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, STERILE T2 FEMUR 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	07/04/2023
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
The customer reported that "use the 4.2 x 340mm drill bit to hole to prepare for insertion of the locking screw 5mm locking screw.The drill bit broke, a second one was used and again broke, the pieces were pieces were recovered".
Event or Problem Description
The customer reported that "use the 4.2 x 340mm drill bit to hole to prepare for insertion of the locking screw 5mm locking screw.The drill bit broke, a second one was used and again broke, the pieces were pieces were recovered".
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog #, d4 lot # and h6 method codes.The reported event could be confirmed, since the device was returned and matches the alleged failure.The received drill was inspected visually and with the help of a microscope, where we can see that the breakage surface is showing typical characteristics of the ductile overload fracture where we can see permanent distortion of material and a visible shear lip is available.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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 be user related if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO, STERILE T2 FEMUR 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: 17414199
• Report Number: 0009610622-2023-00269
• Device Sequence Number: 7182034
• 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: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 18064260S
• Device Lot Number: KU151382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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