MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 APG+ SIZER PIN GUIDE 40+0; PIN GUIDES

Catalog Number	223600001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
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
It was reported that the apg + sizer pin guide was found broken.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #: (b)(4).Investigation summary: the complaint sample consisted of (1) 223600001 apg+ sizer pin guide 40+0, lot code pg236972.Lot pg236972 was released for distribution on february 19, 2014.Examination of the returned apg+ sizer pin guide 40+0 confirmed the reported breakage.The device has broken into two pieces.All pieces of the device were returned.The damage is due to repetitive contact with the hex driver.The overall condition of the devices indicate heavy usage.A worldwide complaint database search found no additional reports against the complaint sample product code/lot code combination.The root cause is attributed to device wear from normal use and servicing.Based on the root cause determination of device wear from normal use and servicing, the need for corrective action is not indicated.Monitor complaints through post market surveillance sep-419.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.

• Brand Name: APG+ SIZER PIN GUIDE 40+0
• Common Device Name: PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7352377
• Report Number: 1818910-2018-55531
• Device Sequence Number: 13470557
• Product Code: HWT
• UDI-Device Identifier: 10603295105688
• UDI-Public: 10603295105688
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/26/2018

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: 223600001
• Device Lot Number: PG236972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 07/27/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/18/2018; 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1