MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 3 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number	254500733
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the attune femoral trials are worn and damaged with pieces of plastic missing.The surgeon have complained and requested that the trials be replaced.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported trial damage.Damage to the femoral groove was found which is consistent with saw blades coming in contact with the device.The root cause is attributed to inadvertent user error.Based on the root cause of user error, corrective action is not indicated.Continue to monitor via (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported trial damage.Damage to the femoral groove was found which is consistent with saw blades coming in contact with the device.The root cause is attributed to inadvertent user error.Based on the root cause of user error, corrective action is not indicated.Continue to monitor via (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM TRIAL SZ 3 LT
• Common Device Name: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; depuy ireland - 9616671; cork, munster ; EI
• MDR Report Key: 7517906
• Report Number: 1818910-2018-59718
• Device Sequence Number: 13918982
• Product Code: JWH
• UDI-Device Identifier: 10603295134053
• UDI-Public: 10603295134053
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2018

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 Catalogue Number: 254500733
• Device Lot Number: MVMAYH610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 05/18/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/25/2018; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR