MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID-HANDPIECE/MODULAR FOR TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problems Mechanical Problem (1384); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

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 2 of 2 for the same event.It was reported that during an unspecified surgical procedure it was observed that the handpiece device and lid device mode selector would not move when the devices were used together.It was reported that the modular saw device and lid device operated intermittently at times during the procedure.It was reported that there was no delay in the procedure due to the event as the same products were used to successfully complete the procedure.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LID-HANDPIECE/MODULAR FOR TRS
• 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: 5609431
• MDR Text Key: 44459312
• Report Number: 8030965-2016-13452
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Device Lot Number: 100281
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1