MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ACTIS BROACH SIZE 7; HIP INSTRUMENT - BROACH

Catalog Number 301001070

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

It was reported that device was received without allegation.Visual exam of the received device found the broach post is bent.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the following device was received as blind unit.Product code: 301001070, lot no - pg331590, tracking no -(b)(4).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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the actis broach size 7 was found slightly bent from the post, light nicks were observed around the post.No other issues were observed.A functional test was performed with a mating device (952210500f) revealed that the broach was not able to fully seated with the handle.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces such as impaction forces and prying motion while the broach is not fully seated with the mating device.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: ACTIS BROACH SIZE 7
• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18669668
• MDR Text Key: 335966604
• Report Number: 1818910-2024-02712
• Device Sequence Number: 1
• Product Code: QBO
• 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
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301001070
• Device Lot Number: PG331590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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