MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 3.5 CANNULATED SCREWDRIVER

Catalog Number	230793000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: intraoperatively the instrument fractured into two or more pieces.No adverse patient consequences, no surgical delay reported.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the 3.5 cannulated screwdriver had the tip broken.Fragment was not returned for evaluation.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 3.5 cannulated screwdriver would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 08-march-23.3) any anomalies or deviations identified in dhr: no anomalies nor deviations.4) expiry date: n/a.5) ifu reference: w90966.Device history review: a manufacturing record evaluation was performed for the finished device product description: 3.5 cannulated screwdriver product code: 230793000 lot number: 5518714 and no non-conformances or manufacturing irregularities were h11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that intraoperatively, the instrument fractured into two or more pieces.No adverse patient consequences, no surgical delay reported.Sales representative confirmed that there was material defect, but the screwdriver was tilted by the sales representative.

• Brand Name: 3.5 CANNULATED SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20822456
• Report Number: 1818910-2024-24657
• Device Sequence Number: 12683561
• Product Code: HXX
• UDI-Device Identifier: 10603295116585
• UDI-Public: (01)10603295116585(10)5518714
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 230793000
• Device Lot Number: 5518714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/10/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/18/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown