MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LID FOR BATTERY HANDPIECE MODULAR, TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.227

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The reporter¿s complete address was not provided.The manufacturing location was unknown.The serial number was unknown.Therefore, device manufacture date is unknown.Concomitant medical 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 Description

This is report 8 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 closed without any issues.The 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Concomitant medical 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 8 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.

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: LID FOR BATTERY HANDPIECE MODULAR, TRS
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7292759
• MDR Text Key: 100832236
• Report Number: 8030965-2018-51335
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819978041
• UDI-Public: (01)07611819978041
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.227
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1