MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 9 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number	254500739
Medical Device Problem Codes	Crack (1135); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The investigation attributed the root cause to unintended user error.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 evaluation of the returned device finds the trial is cracked, and scratched/nicked.The crack was located the color coded indicator and damage to the medial aspect of the trial flange was found which is consistent with saw blades coming in contact with the device.The overall condition of the device indicates moderate usage.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 femoral trial was cracked across the anterior flange when going to trial the femoral component.The femoral component remained in one piece.It was not in two pieces.All parts were retrieved and no one indicated a problem with the components.Surgery was not delayed.

• Brand Name: ATTUNE PS FEM TRIAL SZ 9 LT
• Common Device Name: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8896670
• Report Number: 1818910-2019-101154
• Device Sequence Number: 1400349
• Product Code: JWH
• UDI-Device Identifier: 10603295134114
• UDI-Public: 10603295134114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254500739
• Device Lot Number: MVMBSZ370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR