MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS FEM BROACH SIZE 3; HIP INSTRUMENT - BROACH

Model Number 4840-03-100

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that broach was not come off insertion handle.It was unknown, if there was a surgical delay.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that broach was not come off insertion handle.It was unknown, if there was a surgical delay.>> the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found circular scratches around the post.Additionally, the post appeared slightly bent downwards.The unable to disassemble condition cannot be confirmed as the broach was returned disassembled from its mating device.No other issues were identified.The observed condition of the device can be attributed to unintended use error, the device's post scratches can be attributed to a combination of heavy usage and due to the taper not being seated all the way into the mating device before usage.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was performed with the mating broach handle (259807550), the assembling/disassembling process was slightly difficult to perform most likely due to the deformation of the post where it mates to the handle.The complaint condition was able to be replicated.The overall complaint was confirmed as the observed condition of the emsys fem broach size 3 would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error.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.H3.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: EMSYS FEM BROACH SIZE 3
• Type of Device: HIP INSTRUMENT - BROACH
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16208988
• MDR Text Key: 308036866
• Report Number: 1818910-2023-01540
• Device Sequence Number: 1
• Product Code: QBO
• UDI-Device Identifier: 10603295513711
• UDI-Public: 10603295513711
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/19/2023

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 Model Number: 4840-03-100
• Device Catalogue Number: 484003100
• Device Lot Number: SO2054757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 09/04/2023; 09/13/2023
• Supplement Dates FDA Received: 09/05/2023; 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Female