MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ADV+ BROACH HANDLE; EXTREMITY INSTRUMENTS : HANDLES

Catalog Number	212801850
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
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 humeral broach handle was not locking making difficult to remove broach in humerus.Surgeon had to find an additional instrument to assist him in removing broach.Product is being returned for repair/replace.Surgical delay: 3-4 mins.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: (b)(4).The device associated with this report was not returned for examination.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.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: ADV+ BROACH HANDLE
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7553513
• Report Number: 1818910-2018-60853
• Device Sequence Number: 16473294
• Product Code: LXH
• UDI-Device Identifier: 10603295088158
• UDI-Public: 10603295088158
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/02/2018

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: 212801850
• Device Lot Number: NW117970
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR