MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID FOR HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problems Fracture (1260); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 03/31/2015

Event Type  Injury  

Event Description

This is report 4 of 6 for the same event.It was reported from (b)(6) that during an unspecified osteotomy surgical procedure, it was observed that the two battery handpiece devices and two lid devices did not work together.According to the report, the mode selector switch stopped at lock position and would not go any further even with force.It was reported than when the device was pushed down hard enough, the user was able to switch positions sometimes.A small battery drive device with short and thin saw-blade device was available and used to continue the procedure.According to the reporter, there were complications of an additional fracture and bleeding.It was reported that these complications were treated by the surgeon.It was not reported what medical intervention was performed to treat the complications.As a result, there was a 45 minute extension to the surgical procedure.The patient status/outcome was ¿ok¿.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Initial reporter¿s phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

During subsequent follow-up with the customer additional information was received.The reporter clarified that the nurse and surgeon tried to mount the battery handpiece devices and the problem with the lid devices was not detected prior to surgery.Local distributor was contacted and while waiting for the product specialist, the surgery was continued with the colibri (small battery drive) device (patient was under anaesthesia) as it was the only device available in the clinic.According to the reporter, some time was spent obtaining a spare device.The reporter clarified that both handpiece and lid devices had the same issue.It was reported that the bleeding was caused by a sharp bone edge as a result of the short saw blade device, "blade of a similar sized trauma recon system device was not available".Reporter stated that some time was required to stop the bleeding to maintain homeostasis.The bone electrical coagulation and diathermia treatment were performed.It was reported that the battery handpiece and lid devices were not used during surgery.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the housing was deformed and bent.Therefore, the reported condition was confirmed.The device was fully dismantled and it was determined that a failing unlock mode mechanism was related to deformation of locking plate.It was determined that subsequent damage due to handling problems originated in the deformation of housing on the handpiece device could be detected in several parts.It was further determined that the locking mechanism of the device relied on proper interaction between the handpiece and the housing.It was determined that due to a deformed housing the locking slide of the lid device could be blocked in its movement into the housing locking notch.The assignable root cause was determined to be due to faulty design/construction.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 HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4737904
• MDR Text Key: 5773149
• Report Number: 3009450871-2015-11192
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMALL BATTERY DRIVE DEVICE; SAW BLADE DEVICE; BATTERY HANDPIECE DEVICE; LID FOR HANDPIECE DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR