MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO GAMMA3 4,2X360 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3642
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/12/2020
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
As reported: "broken drill bit during gamma nail distal locking drilling, retained within nail [.]".
Event or Problem Description
As reported: "broken drill bit during gamma nail distal locking drilling, retained within nail.
Additional Manufacturer Narrative
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 signs of intense usage.The drill was found to be broken from the shaft region.The cutting edges of the drill are absolutely blunt and severe material deformation and damage can also be seen around it.The breakage surface reveals a partial smooth surface as well as partial plastic deformation.This confirms a ductile overload fracture due to prolonged usage.All these signs are evident enough to suggest that there was an intense usage of the drill including high torsional and bending load which lead to a forced fracture.The critical diameter of the drill was observed to be 4.15mm as required against a range of 4.10mm - 4.20mm.Similarly, the average hardness of the drill was observed to be 53.8 hrc as required against a range of 52.0 hrc ¿ 56.0 hrc.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.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 ductile nature of the breakage.Moreover, it was observed that the remaining cutting edges of the drill tip returned were significantly worn and covered with dents; the drill is not sharp anymore.As the device had been in use for quite a long period of time (manufactured in 2010), it can be said that the device had fulfilled its tasks in former surgeries as intended without any problems reported.A review of the labeling did not indicate any abnormalities.The ifu clearly instructs the user that: ¿ensure that the drilling and cutting tools to be used are sharp; discard them if they are not.¿ if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO GAMMA3 4,2X360 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
• MDR Report Key: 10358291
• Report Number: 0009610622-2020-00423
• Device Sequence Number: 16946222
• Product Code: LXH
• UDI-Device Identifier: 04546540576798
• UDI-Public: 04546540576798
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 1320-3642
• Device Catalogue Number: 13203642
• Device Lot Number: K121364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1