MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 HUMERUS Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during t2 proximal humerus nail surgery the drill broke off.The drill was broken during drilling at proximal a/p locking hole.The broken drill tip was removed by opening a new small wound." additionally it was reported that there was a 30 minute surgical delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown that the drill bit is broken apart at the crossover from the cutting flutes to the shaft, the breakage is clean and no small fragments were generated.At the cutting edges are many strong nicks and dents on both sides of the edges visible and the tip is at the forefront blunt.These damages indicate that either the use of a blunt instrument, an excessive metallic contact or a combination of both factors did lead to a mechanical overload and finally the breakage of the drill bit.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, a hardness test according to rockwell on the returned item indicates the material being in accordance to 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.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 investigation with the above described damages, the root cause was attributed to a user related issue.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during t2 proximal humerus nail surgery the drill broke off.The drill was broken during drilling at proximal a/p locking hole.The broken drill tip was removed by opening a new small wound." additionally it was reported that there was a 30 minute surgical delay.

• Brand Name: DRILL, AO T2 HUMERUS Ø3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 17602279
• Report Number: 0009610622-2023-00292
• Device Sequence Number: 6125883
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: 04546540196606
• 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): 11/06/2023

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 Catalogue Number: 18063540
• Device Lot Number: KU111395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• 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 Sex: Unknown