MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3 4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The customer reported that : "during the procedure, while drilling the gamma nail lock, the drill bit broke off and remained in place in the femur.The attempt to remove it was unsuccessful.As a result, the device had to be changed and the operation time was longer than expected." it was further reported that the surgical delay was slight.There were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
D4 lot# corrected; h6 device code changed.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received drill shows significant signs of usage.The drill was found to be broken close to the tip.The cutting edges of the drill appeared to be slightly dull.The breakage surface reveals a relatively smooth surface and absence of any plastic deformation.This confirms a brittle fracture due to high bending load leading to a forced fracture.As per the dimensional inspection, the returned drill was found to be within specifications.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.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 of the failure is user related.Manner of breakage indicates that the breakage of the drill most likely happened due to a bending overload during the surgery.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that : "during the procedure, while drilling the gamma nail lock, the drill bit broke off and remained in place in the femur.The attempt to remove it was unsuccessful.As a result, the device had to be changed and the operation time was longer than expected." it was further reported that the surgical delay was slight.There were no reported adverse consequences to the patient.

• Brand Name: DRILL, AO SMALL GAMMA3 4.2X300MM
• 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: 12264220
• Report Number: 0009610622-2021-00629
• Device Sequence Number: 4860732
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• 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): 10/21/2021

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: 1320-3042
• Device Catalogue Number: 13203042
• Device Lot Number: KU80511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1