MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ STRAIGHT HANDLE OUTER; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Catalog Number	223000025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Handle (2230-00-025) would not fit into either rasp guide 2230-10-282 or peripheral drill guide (2230-00-081).This forced the surgeon to use kochers to set the guides which lacked stability while performing surgical steps associated with each piece.This caused 10 minutes of additional surgical time.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device was received.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.Device history lot = > null.Device history batch = > null.Device history review = > null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APG+ STRAIGHT HANDLE OUTER
• Common Device Name: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7872213
• Report Number: 1818910-2018-69226
• Device Sequence Number: 192525
• Product Code: LXH
• UDI-Device Identifier: 10603295102984
• UDI-Public: 10603295102984
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 223000025
• Device Lot Number: PC3366436
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1