MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ3; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500543

Device Problems Component Missing (2306); Contamination /Decontamination Problem (2895); Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 several instruments were discovered to be damaged during the decontamination process by reprocessing staff.The attune femoral impactor attachment has a cracked on the top surface.Size 3 attune rp ps artic surf had a spring come off while being cleaned.Size 6 attune rp ps artic surf also had a spring come off while being reprocessed.There were no patients involved in the incidents.Surgery time was not extended.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary : examination of the returned device confirms the reported event.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ3
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 9432361
• MDR Text Key: 187768347
• Report Number: 1818910-2019-121696
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132837
• UDI-Public: 10603295132837
• Combination Product (y/n): N
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500543
• Device Lot Number: MVMCJG170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1