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	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Concomitant med products: battery handpiece/modular device, lid devices, power module device, insertion shield devices.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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
This is report 6 of 8 for the same event: it was reported from (b)(6) that during an open reduction internal fixation (orif) of the femoral fracture surgery, it was discovered that the power module device was set in the battery handpiece device using three sterile insertion shield devices; however, the battery handpiece device could not be closed with three lid devices.It was further reported that several unsuccessful attempts were made.It was reported that another set of the power module device was set in and the lid was able to be close without any issues.There surgery was completed with a three minute delay.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.According to the reporter, the surgeon commented that the same phenomenon did not happen though they tried the same thing after the surgery.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Correction: upon subsequent follow-up with the affiliate, additional information was received.The reporter clarified that there were no alleged malfunction against one of the lid devices and the insertion shield devices.Thus, two sterile insertion shield devices; and two lid devices were used in this event.Therefore, the lid and the insertion shield devices has been excluded in this event and removed from the concomitant medical products section.Furthermore, the event numbering represented in the initial report has been updated from ¿report 6 of 9 for the same event¿ to ¿report 6 of 7 for the same event¿.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was not confirmed.A functional assessment was performed and the device passed all tests and no failures were identified.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Concomitant med products: battery handpiece/modular device, lid devices, power module devices, insertion shield devices.Upon subsequent follow-up with the affiliate, additional information was received.The reporter stated that an additional power module was used during the reported event.Therefore, this is report 6 of 9 for the same event.Concomitant medical products has been updated accordingly.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 7292758
• Report Number: 8030965-2018-51169
• Device Sequence Number: 16458994
• Product Code: HWE
• UDI-Device Identifier: 07611819977839
• UDI-Public: (01)07611819977839(11)111130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 01/29/2018

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: 05.001.203
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/15/2018; 03/13/2018; 04/03/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/07/2018; 03/21/2018; 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1