MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PATELLA COMPRESSION RNG; PATELLA HANDLE/CLAMPS

Catalog Number 254501042

Device Problem Break (1069)

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

Event Date 01/01/2024

Event Type  malfunction  

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.

Event Description

Unfortunately no lot number is available as this happened some time ago.The rep doesn¿t have op date or any further detail, please see below: device breakage and repair.

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 that 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:according to the information received, "[device breakage and repair]" ¿the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).Re: medical complaint: patella button).The photo investigation revealed that the device 254501042, attune patella compression rng had part of material chipped off.The potential cause is attributed to suspected misuse/mishandling during disassembly for sterilization purposes against recommendations.¿since the device was not returned, a dimensional inspection cannot be performed.¿the overall complaint was confirmed as the observed condition of the device 254501042, attune patella compression rng would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Event Description

Additional information was received: 1.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? - as per photo, rubber ring broken, small amount of rubber has come off the ring 2.Was there a surgical delay? if yes, what is the duration of the delay? - no delay 3.Was there any adverse consequences that affected the patient because of the reported event? - no 4.Did it break into two or more pieces? if no, please specify the alleged deficiency of the instruments.Were they bent, stripped, cross threaded, etc.? - no.

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.H10 additional narrative: corrected: b5, e1 (hospital) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PATELLA COMPRESSION RNG
• Type of Device: PATELLA HANDLE/CLAMPS
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18844473
• MDR Text Key: 336971022
• Report Number: 1818910-2024-05075
• Device Sequence Number: 1
• Product Code: HWN
• UDI-Device Identifier: 10603295395454
• UDI-Public: 10603295395454
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254501042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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