MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC INSERTION SHIELD FOR TRAUMA RECON SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.203
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the insertion shield for trauma recon device was broken.It was not reported if there were any no delays to the surgical procedure.A spare device was available for use and the surgical procedure was completed.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The manufacturing site name was documented as (b)(4) in the initial report.This has been updated to (b)(4).Please note that the contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.

• Brand Name: INSERTION SHIELD FOR TRAUMA RECON SYSTEM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7067778
• Report Number: 8030965-2017-50150
• Device Sequence Number: 127152
• Product Code: HWE
• UDI-Device Identifier: 07611819977839
• UDI-Public: (01)07611819977839(11)101110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: 05.001.203
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1