MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL ADVATAGE BROACH 10MM; EXTREMITY INSTRUMENTS : BROACHES

Catalog Number	212860010
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device did not confirm the reported crack.The device revealed cuts and scratches attributed to normal use and servicing.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 will be filed as appropriate.
Event or Problem Description
It was reported that the anterior portion of the 10mm broach has cracked.

• Brand Name: GLOBAL ADVATAGE BROACH 10MM
• Common Device Name: EXTREMITY INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7999139
• Report Number: 1818910-2018-73334
• Device Sequence Number: 1311195
• Product Code: HTQ
• UDI-Device Identifier: 10603295089148
• UDI-Public: 10603295089148
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 212860010
• Device Lot Number: U3DBF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1