MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ROD FOR REAMING GUIDE HOLDER; ORTHOPEDIC INSTRUMENT HANDLE

Catalog Number 230774002

Device Problem Material Deformation (2976)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4) investigation summary according to the information received, ¿instruments bent while in use, no other issues in the case but it is now not usable".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 rod for reaming guide holder has the distal tip bent.The overall condition of the device exhibits signs of normal and constant usage.No other defects were found.It is worth mentioning that the mating device (holder for reaming guides) was returned for evaluation and nothing indicative of a device nonconformance or defects that could have contributed to the reported event were observed.A functional test performed with the mating device revealed that the od for reaming guide holder was not able to be assemble as intended due to the observed deformation of the tip.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended and excessive forces, such as fretting and torsional bending from contact with the outer unit of the reaming guide impactor during use.The overall complaint was confirmed as the observed condition of the rod for reaming guide holder 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.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 the holder is bent.Was surgery delayed due to the reported event? no, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no patient involvement, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

• Brand Name: ROD FOR REAMING GUIDE HOLDER
• Type of Device: ORTHOPEDIC INSTRUMENT HANDLE
• 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: 18874352
• MDR Text Key: 337408975
• Report Number: 1818910-2024-05521
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295116134
• UDI-Public: 10603295116134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170748
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230774002
• Device Lot Number: 5381055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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