MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Catalog Number 230792003

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Locking screwdriver was deemed to be damaged during surgery by the surgeon and they were unable to use to insert screws as required.The screw driver was removed and a replacement was immediately found, the hospital keeps a back up sterilized for if this occurs or the item is dropped, so very limited wait time while this was retrieved and brought into surgery.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: locking screwdriver (item #:230792003, tray #: zzinnze0012) was deemed to be damaged during surgery by the surgeon and they were unable to use to insert screws as required.The screw driver was removed and a replacement was immediately found, the hospital keeps a back up sterilized for if this occurs or the item is dropped, so very limited wait time while this was retrieved and brought into surgery.Have requested from theatre staff that following decontamination can the item please be returned to us so we can organize delivery back to auckland customer service.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the locking screwdriver body found that the one of the four prongs on the distal end of the device was broken.The broken fragment was not returned for evaluation.The unable to assemble can be related to the broken issue.The allegation can be confirmed.The fracture issue of the locking tabs has been addressed through depuy synthes quality system with a design change in 2020.The first batches (5357743 and 5357744) of drivers per the new design were manufactured on february 7, 2020.The current complaint sample device was manufactured prior to the implementation of the new design.However, due to the device was manufactured in 2018, the device has been in service over 5 years and shows signs of heavy repeated used.Therefore, the potential cause for failure is traced to end of life.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the locking screwdriver body would have contributed to the complained 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.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.

• Brand Name: LOCKING SCREWDRIVER BODY
• Type of Device: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18725719
• MDR Text Key: 336622358
• Report Number: 1818910-2024-03586
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230792003
• Device Lot Number: 5311341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2018
• 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