MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-4260
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
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
As reported: "after compression of both the talofemoral and talocalcaneal joints, a drill fracture occurred when drilling into the calcaneus from the lateral side.They gave up on the hole and moved on to the posterior calcaneal screw insertion technique.After drilling and measuring with a depth gauge, the screw was inserted, but it was found that the screw had ob'd.The screw was removed and the drill was broken when drilling again.Two screws that could be inserted into the calcaneus through the nail were not inserted.Instead, two screws were inserted by freehand drilling from outside the nail.No broken pieces of the drill were left behind in the body." this resulted in a 30 minute surgical delay.
Event or Problem Description
As reported: "after compression of both the talofemoral and talocalcaneal joints, a drill fracture occurred when drilling into the calcaneus from the lateral side.They gave up on the hole and moved on to the posterior calcaneal screw insertion technique.After drilling and measuring with a depth gauge, the screw was inserted, but it was found that the screw had ob'd.The screw was removed and the drill was broken when drilling again.Two screws that could be inserted into the calcaneus through the nail were not inserted.Instead, two screws were inserted by freehand drilling from outside the nail.No broken pieces of the drill were left behind in the body.".This resulted in a 30 minute surgical delay.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the received drill shows significant signs of usage, the drill is completely broken in two ends both ends are available for analysis.The broken surface is brittle in nature, evident by a relatively smooth and shiny surface, caused most likely due to torsional and bending overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.From the available radiographs, a formal medical opinion was sought: from the radiographs it is hard to confirm about hard bone, maybe there is some sclerotic bone, but bone being too hard for drilling cannot be confirmed.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 the investigation, the root cause was attributed to being user related.The appearance of a breakage surface indicates towards a forced brittle fracture caused most likely due to torsional and bending overload.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 FEMUR Ø4,2X340 MM
• 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
• 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: 16441208
• Report Number: 0009610622-2023-00067
• Device Sequence Number: 16931590
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Model Number: 1806-4260
• Device Catalogue Number: 18064260
• Device Lot Number: KU151538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/26/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: Asian