MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ADV+ IMPACTION BLOCK; IMPLANT STAND

Catalog Number	212802050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional 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
Der states that the surgeon was assembling the cta head and stem on back table.While malleting the implants together the blue plastic flakes broke off onto the back table.There was some evident damage to the assembling tower.The surgeon also washed off the implant to possibly remove any residual particles.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ADV+ IMPACTION BLOCK
• Common Device Name: IMPLANT STAND
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7285207
• Report Number: 1818910-2018-53783
• Device Sequence Number: 1455358
• Product Code: HWA
• UDI-Device Identifier: 10603295088196
• UDI-Public: 10603295088196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 02/01/2018

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: 212802050
• Device Lot Number: NW137077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65