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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the drill bit broke during surgery.Attempts made to retrieve the broken part from the patient were unsuccessful; the broken part was left in the patient.No adverse consequence to the patient has been reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the tip of the drill is broken, as reported.The edges are slightly damaged just proximally from the breakage area.There are nicks and dents all over the edges visible.The breakage surface reveals typical characteristics of a brittle fracture i.E.Relatively smoother surface at the center than at the edges.Since the breakage was brittle (sudden) in nature, there is evidence of abrupt features especially by plateau on both sides of the fracture face.Furthermore, this device has been manufactured in october 2010, which means it has been used for over 10 years.The normal wear of the device could also have participated in the reported breakage.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mix of natural wear and mishandling due to overloading of the device.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the drill bit broke during surgery.Attempts made to retrieve the broken part from the patient were unsuccessful; the broken part was left in the patient.No adverse consequence to the patient has been reported.

• 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: 11827187
• Report Number: 0009610622-2021-00515
• Device Sequence Number: 4308337
• 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): 09/16/2021

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: 1320-3642
• Device Catalogue Number: 13203642
• Device Lot Number: K128656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1