MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION SYSTEM HANDLE; HANDLES

Model Number	2546-00-100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
Slap hammer broke off in revision impactor.Rubber was broken in attune impactor.Did the event occur during sterile processing? unknown, did the event occur during field inspection? unknown, did the event occur during internal service activities such as calibration? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(4): device property of: none, device in possession of: none, (b)(4): device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device found that the slap hammer had broken off inside the handle.The broken off fragment of the slap hammer was not returned for evaluation.The portion of the slap hammer that is broken off inside the handle cannot be removed for evaluation of the slap hammer fragment or the obstructed mating threads of the handle.The overall condition of the guide reveals general wear indicating it has been used multiple times.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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.

• Brand Name: ATTUNE REVISION SYSTEM HANDLE
• Common Device Name: HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10306245
• Report Number: 1818910-2020-16475
• Device Sequence Number: 19410826
• Product Code: HWA
• UDI-Device Identifier: 10603295438731
• UDI-Public: 10603295438731
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/13/2020

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: 2546-00-100
• Device Catalogue Number: 254600100
• Device Lot Number: AB4187356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1