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 Operates Differently Than Expected (2913)
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).The serial number was unknown.Therefore, device manufacture date is unknown.Concomitant med products: battery handpiece/modular device, lid devices, power module device, insertion shield devices.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 7 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
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 7 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.
Additional Manufacturer Narrative
During subsequent follow-up, it was clarified that there was no alleged malfunction against the lid device and the insertion shield device.Therefore, it was determined that this event could not have caused or contributed to a serious injury and/ or death.Reporting for this event is therefore completed.The initial report is being retracted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 7292748
• Report Number: 8030965-2018-51334
• Device Sequence Number: 1066893
• Product Code: HWE
• UDI-Device Identifier: 07611819977839
• UDI-Public: (01)07611819977839
• 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
• 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?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/13/2018; 04/03/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 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