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

Model Number	2545-00-503
Medical Device Problem Codes	Break (1069); Component Missing (2306); Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that they have several items that the central sterile department wants replaced, due to broken pieces.I have 2 artic surf pieces missing springs.I have 1 artic surf missing an entire prong, they do not have missing prong, there was just a hole where it used to be.They have impaction handle that the red triggers as broken off, they have all 3 pieces, handpiece, trigger, and spring.None of these items were broken in surgery, none of these items delayed a surgery, no one was injured by these items.They are broken, missing pieces from normal wear and tear.
Additional Manufacturer Narrative
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.H10 additional narrative: added: d10.Corrected: h3 and h6 (device).

• Brand Name: ATTUNE FB PS ARTIC SURF SZ3
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10309767
• Report Number: 1818910-2020-16583
• Device Sequence Number: 19675603
• Product Code: HWT
• UDI-Device Identifier: 10603295132431
• UDI-Public: 10603295132431
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2545-00-503
• Device Catalogue Number: 254500503
• Device Lot Number: MVMBSX200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1