MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE ANGLED IM ROD 160MM; ANGLED ROD

Catalog Number IGB0665

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

I want to report a complaint for a product that has just been received by a surgeon.I have tried multiple times to report this through cst and it has crashed / failed on each.Prof received some new custom made instrumentation yesterday.Prior to clinical use he inspected the kit and it¿s assembly with other parts of the instrument system.No patients were involved as the inspection was carried out in his office.He reported difficulty fully assembling two part of the new instrument kit with one part of the existing set.He reported the complaint yesterday.The affected codes in the new instrumentation kit are: igb0664 igb0665 the standard part that would not fully assemble was: 254400512 prof does not feel that the lack of complete assembly will have little effect on the use of the instruments and does not wish to return them.

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).Information was received indicating that "following further communication with the surgeon the 254400512 device was replaced with a new one from stock, this completely resolved the assembly issue with the other mating parts.Based on this, there is evidence that none of the igb0664 or igb0665 instruments are the origin of this issue." 254400512 device has been reported under 1818910-2022-09682.Due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE ANGLED IM ROD 160MM
• Type of Device: ANGLED ROD
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14744674
• MDR Text Key: 303226226
• Report Number: 1818910-2022-11302
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGB0665
• Device Lot Number: 9837939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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