MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE RP TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Catalog Number 254401004

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

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 black attune rp impactor has cracked in half during impaction (lot au6149341) of the tibia in a procedure.A pieces have been retrieved and was being sent back to depuy.Attachment peg for the art surface has snapped off the back side of the artic surf sz8 (lot mvmcjt990) during trialing.All pieces have been retrieved from the patient and the instrument was being sent back to depuy.Attune shim sz 7/8 x 10mm has cracked through the center of the shim.No parts are broken off and the shim was still in one piece.This part was being sent back to depuy.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: the investigation of the returned device confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.Device history lot: null.Device history batch: null.Device history review: null.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 TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8680424
• MDR Text Key: 147383275
• Report Number: 1818910-2019-95523
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130208
• UDI-Public: 10603295130208
• Combination Product (y/n): N
• 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: 05/21/2019

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: 254401004
• Device Lot Number: AU6149341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR