MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 5 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-715

Device Problems Material Discolored (1170); Illegible Information (4050)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(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 the color markings are wearing off (12 trials).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary :examination of the returned device confirmed the reported event.The noted damage is consistent with wear due to many cycle of use in the field.The investigation did not establish a need for corrective action.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.H10 additional narrative: added: d10 and h6 (device).

• Brand Name: ATTUNE CR FEM TRIAL SZ 5 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10460464
• MDR Text Key: 204571050
• Report Number: 1818910-2020-18897
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295133872
• UDI-Public: 10603295133872
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-715
• Device Catalogue Number: 254500715
• Device Lot Number: MVMCFL380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1