MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.The device serial or lot number was unknown.Reporter¿s complete mailing address was not provided.The manufacturing location was unknown.Device manufacture date was unknown.Concomitant medical devices and therapy dates: power module device, k-wire device, guide sleeve device, nail device and drill bit devices, (b)(6) 2020.Other concomitant devices reported under: mfr 8030965-2020-03646 - drill bit device, mfr 8030965-2020-03656 - guide sleeve device, mfr 8030965-2020-03658 - drill bit device, mfr 8030965-2020-03662 - nail device.Udi: (b)(4).

Event Description

It was reported from (b)(6) that while setting up for a femoral trochanteric fracture procedure, it was observed that the battery handpiece device was did not work and made a small mechanical sound.According to the reporter, a second attempt was made and the power module device was replaced, however the device still did not work.It was reported that due to the battery handpiece not working, the user had to manually ream up to 11 mm and select 130 ° f10 mm-280 mm to secure the lock settings and insert nails.It was reported that a competitor system was used to continue and complete the initial part of the procedure.One the proximal fixation was complete, the user set up another system consisting of a guide sleeve device, a nail device, and a drill bit device for the drilling and implantation of hardware/fixation.It was reported that the nail device was then inserted.After fixation of the proximal hole, the user attempted to drill the distal hole, however the drill device interfered with the nail device.It was noted that the distal hole of the nail device had shifted to a proximal position and the screw was loosened.It was reported that the proximal hole was already fixed, so the user decided to no longer use the replacement system and chose to fix the hole distally using another method.The user tried to drill using a drill bit device, however it was too long and interfered with the image intensifier.As an alternative solution, the user created the holes and drilled without image intensifier using a k-wire device.It was reported that the operation was completed by inserting two screws distally.However, the procedure was delayed by sixty minutes due to the event.It was noted that the patient had a rheumatism and was given a blood transfusion during the surgery, which was not planned before the surgery.There was patient involvement reported.There were no injuries or prolonged hospitalization reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D4: the device serial number was reported as unknown in the initial report and has been updated accordingly.The udi has been updated accordingly.G1-2: the manufacturer location was unknown in the initial report.The location has been updated to oberdorf.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.H4: the device manufacture date was reported as unknown in the initial medwatch report.This has been updated to aug 2, 2018.Udi: (b)(4).

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During evaluation by quality engineering it was observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.During review of the device manufacturing records for this device it was found that there were no anomalies that occurred during the manufacturing or processing of the device that would have been expected to cause or contribute to the reported event.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10113798
• MDR Text Key: 198789973
• Report Number: 8030965-2020-03540
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 07611819977815
• Combination Product (y/n): N
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 75