MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION; RECLAIM INSTRUMENTS : ADAPTORS

Catalog Number 297500500

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that the white sleeve on the reamer handle was sliding off the shaft and the inner spring in the white sleeve was missing.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? - no, did the patient require revision surgery or hardware removal? - no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?- no, patient status/ outcome / consequences - no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: - no, is the patient part of a clinical study - unknown, ip-01828100 device property of - other, device in possession of - 1.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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: RECLAIM DIST REAMER EXTENSION
• Type of Device: RECLAIM INSTRUMENTS : ADAPTORS
• 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: 17690984
• MDR Text Key: 322740426
• Report Number: 1818910-2023-18225
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295155911
• UDI-Public: 10603295155911
• 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
• Report Date: 09/06/2023

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 Catalogue Number: 297500500
• Device Lot Number: NB93820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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