MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR HEAD BALL REMOVER; EXTRACTION INSTRUMENTS

Catalog Number 212500600

Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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

It was reported that instruments were broken upon inspection.Modular head ball remover had a knick on end and had trouble attaching at times.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: it was reported that instrument were broken upon inspection.Attune rev tibial prep tower was bent, and did not slide in base plate.The angle drill did not turn and also stuck.The turn knob of the attune femoral introducer was broken.Modular head ball remover had a knick on end and had trouble attaching at times.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal fluted tip of the modular head ball remover was found stripped, consistent with repeated use and servicing.Additionally, the connection end of the device was found scratched and deformed.A functional test was performed with the mating device (d200142000) and difficulties were found during the assembling process, most likely due to the observed condition of the connection end.No other defects were found.The observed condition of the connection end is consistent with a random component failure that may have been caused by exposure to unintended and excessive forces while handling the device and/or using the device in an off-axis position.The overall complaint was confirmed as the observed condition of the modular head ball remover would contribute to the complained device issue.Based on the investigation findings, 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 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 manufacturing records evaluation (mre) was not performed.

• Brand Name: MODULAR HEAD BALL REMOVER
• Type of Device: EXTRACTION INSTRUMENTS
• 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 ; 3035526892
• MDR Report Key: 18335217
• MDR Text Key: 330602530
• Report Number: 1818910-2023-25386
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295087878
• UDI-Public: 10603295087878
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212500600
• Device Lot Number: SO2059130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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