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

Catalog Number 230793000

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #; (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary:the implant below was opened yesterday for an emergency surgery, however it was not used because it has a gap between the polyethylene and the dome.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the self cent hip 43x28 gry was found the hex tip broken and visible edged rounded, in addition the shaft was worn and the etched lot number information could not be read, fragment was not returned for evaluation.No other issues were identified.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection for the self cent hip 43x28 gry was not performed due to post manufacturing damaged.The overall complaint was confirmed as the observed condition of the self cent hip 43x28 gr would contribute to the alleged device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes 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: a manufacturing records evaluation (mre) was not performed as no lot number was retrieved due to observed condition for this device.If the lot/serial number becomes available, the record will be re-assessed.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 Description

The cannulated screwdriver was received as blind unit however, it couldn't be associated with a complaint or any other existing record.As a result, this complaint was created to analyze the returned device.

• Brand Name: 3.5 CANNULATED SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18219008
• MDR Text Key: 329146173
• Report Number: 1818910-2023-24076
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116585
• UDI-Public: 10603295116585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 230793000
• Device Lot Number: 2585717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1