MAUDE Adverse Event Report: ZIMMER DENTAL LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30; DENTAL DRIVER

Model Number	TW1.25L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that one tw1.25l was fractured.Procedure has been completed with another tool driver.
Additional Manufacturer Narrative
It was reported that two out of three drivers were bent (tw1.25 + tw1.25l) and the third (tw1.25l) was fractured.Zimvie receives one torque wrench hex driver (tw1.25), and two long torque wrench hex drivers (tw1.25l) for investigation (see attached images).Visual/physical evaluation of the returned devices identified bent tips on the tw1.25 and one tw1.25l.The other tw1.25l device had the tip fractured.Note: this investigation addresses the device, first reported tw1.25l.Dhr review for the lot (2020090714) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot (2020090714) and no similar event or complaint was found.The customer did not submit images/x-ray for the reported event.Appropriate documents were reviewed.Based on the investigation and risk management file review as per rmf, the most likely root cause determined from the investigation is inadequate maintenance - device should be inspected and cleaned before each use.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
Use of the short and long tool drivers to unscrew a healing screw in position 16.The unscrewing was very difficult and three instruments were damaged.(2 were bent (tw1.25 + tw1.25l) and the third one was fractured (tw1.25l) ).Procedure has been completes with another tool driver.

• Brand Name: LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30
• Common Device Name: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16776450
• Report Number: 0002023141-2023-01126
• Device Sequence Number: 12516231
• Product Code: NDP
• UDI-Device Identifier: 00889024020207
• UDI-Public: (01)00889024020207(17)991231(10)2020090714
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: Other
• Device Model Number: TW1.25L
• Device Catalogue Number: TW1.25L
• Device Lot Number: 2020090714
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic