MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø3,5X130 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063550
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: nail implantation for fracture by arm wrestling was performed.The patient's bone quality was hard.A radiolucent drill was used to drill the distal side.However, it was difficult to drill the bone.Since there was a hole in the anterior cortex, the surgeon to used the straight drill, which is easier to drill.However, the tip of the straight drill was broken during drilling.The drill bit had broken as it had fit snugly into the nail hole, so the surgeon determined it would be difficult to remove.Thus, the surgery was completed while the broken drill bit was left in the patient's body.
Event or Problem Description
It was reported: nail implantation for fracture by arm wrestling was performed.The patient's bone quality was hard.A radiolucent drill was used to drill the distal side.However, it was difficult to drill the bone.Since there was a hole in the anterior cortex, the surgeon to used the straight drill, which is easier to drill.However, the tip of the straight drill was broken during drilling.The drill bit had broken as it had fit snugly into the nail hole, so the surgeon determined it would be difficult to remove.Thus, the surgery was completed while the broken drill bit was left in the patient's body.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received drill is broken from the tip and the broken fragment was not returned.Broken surface of the drill shows minor chevron lines with relatively smooth surface which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Edges of the drill are slightly deformed and rubbed shiny because most probably the surgeon kept using the broken drill, without noticing it was already broken and because of excess contact in addition to excessive torsional/bending load, it got deformed at the edges.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.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 user related.The event was caused by a mechanical overload during drilling.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 Ø3,5X130 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: 19992621
• Report Number: 0009610622-2024-00793
• Device Sequence Number: 20940704
• Product Code: HWE
• UDI-Device Identifier: 04546540196644
• UDI-Public: (01)04546540196644(10)K0B344D
• 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): 11/13/2024

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
• Device Catalogue Number: 18063550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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: Other
• Patient Sex: Male