MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV RP PS TB TRL SZ9; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-999
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the photo confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
During surgery the surgeon used a hammer to push the trial and shims into place.Two shims and one trial now have cracks in them.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : update 13-aug-2020: the investigation was re-opened upon receipt of the product.Examination of the returned device found the instrument to be broken.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, e1 (facility name).

• Brand Name: ATTUNE CONV RP PS TB TRL SZ9
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10277726
• Report Number: 1818910-2020-15918
• Device Sequence Number: 2526025
• Product Code: JWH
• UDI-Device Identifier: 10603295135760
• UDI-Public: 10603295135760
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 2545-00-999
• Device Catalogue Number: 254500999
• Device Lot Number: BFA0RRN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1