MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWJ111
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill broke off inside the patient and could not retrieved.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the drill broke off inside the patient and could not retrieved.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device reveals extensive usage.The drill is broken around the flute tip, and the broken part is not available for inspection.The fracture patterns at the breakage site being smooth and shiny in appearance are indicative of brittle fracture.The flutes of the device are worn out at the edges.Furthermore, a hardness test according to rockwell hardness tester #(b)(4) on the returned item indicates the material being in accordance: hardness test 1: 54.1/ hardness test 2: 54.1/ hardness test 3: 52.9; required value: 54 hrc ; observed value: 53.7 hrc.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 investigation, the root cause was attributed to a combination of user and wear related issue.The failure was caused by application of high impact torsional forces on the tip during use.Additionally, the fact that the device was manufactured back in 2017 it is safe to say it has performed prior surgeries without any reported abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17777293
• Report Number: 0001649390-2023-00239
• Device Sequence Number: 14994955
• Product Code: HWE
• UDI-Device Identifier: 00846832062348
• UDI-Public: 00846832062348
• 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): 12/13/2023

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: Lay User/Patient
• Device Catalogue Number: MWJ111
• Device Lot Number: BA0417216
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2017
• 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
• Patient Sex: Unknown