MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTND 145 RSA REAM GUID INSRTR; HIP INSTRUMENT : REAM GUIDE INSERTER

Model Number 2307-74-101

Device Problems Device-Device Incompatibility (2919); Unintended Movement (3026)

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

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the handle is loose and will not hold the reamer guides.The event did not happen during surgery.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination found signs of normal usage, however nothing indicative of a device nonconformance was observed.A functional test was not able to be performed since the mating component was not received.The reported allegation cannot be confirmed.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: XTND 145 RSA REAM GUID INSRTR
• Type of Device: HIP INSTRUMENT : REAM GUIDE INSERTER
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16824431
• MDR Text Key: 314103841
• Report Number: 1818910-2023-08887
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295518792
• UDI-Public: 10603295518792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192855
• 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: 04/27/2023

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: 2307-74-101
• Device Catalogue Number: 230774101
• Device Lot Number: FE2053353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 05/29/2023
• Supplement Dates FDA Received: 05/10/2023; 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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