MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STEPDRILL FOR LAG SCREW T2 RECON; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported the following: incident description : during a femoral osteosynthesis, during a change of t2 recon nail, the drill bit broke in the patient's femur.Different solutions searched to extract this , blocked in the collar patient's femur.Drill bit finally extracted, thanks to a prehensive forceps arthroscopy.The operation could then be continued without incident.The drilling having been done, no further device used.Delay:1h30, anesthesia delayed.No immediate consequences on the patient.
Event or Problem Description
The customer reported the following: incident description : during a femoral osteosynthesis, during a change of t2 recon nail, the drill bit broke in the patient's femur.Different solutions searched to extract this , blocked in the collar patient's femur.Drill bit finally extracted, thanks to a prehensive forceps arthroscopy.The operation could then be continued without incident.The drilling having been done, no further device used [.] delay : 1h30, anesthesia delayed no immediate consequences on the patient".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill shows signs of intense usage.The cutting edges of the drill carry a few dents and minor damages.The breakage surface reveals predominantly an abraded surface, although slightly.Slight permanent deformation is also evident.Overall, this amounts to a brittle fracture due to high torsional and bending load which lead to a forced fracture.Severe circular scratch marks all over the outer surface also indicates towards interaction of the drill with a metal object, most likely the sleeve.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The breakage of the drill happened due to a combined torsional and bending overload, evident by the brittle nature of the breakage.If any additional information is provided, the investigation will be reassessed.

• Brand Name: STEPDRILL FOR LAG SCREW T2 RECON
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10553955
• Report Number: 0009610622-2020-00529
• Device Sequence Number: 3538981
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• 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): 11/16/2020

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 Model Number: 1806-3025
• Device Catalogue Number: 18063025
• Device Lot Number: KU75603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR