MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID F/NO. 05.001.201 MOD F/TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problem Mechanical Problem (1384)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported by the (b)(6) that during an unspecified surgical procedure, it was observed that the lid of the handpiece device had an unspecified malfunction.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, 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.

Manufacturer Narrative

The actual device was returned for evaluation.The device was evaluated and the reported condition was not confirmed.An assessment was performed and the device met all manufacture's specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LID F/NO. 05.001.201 MOD F/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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6472632
• MDR Text Key: 72249288
• Report Number: 8030965-2017-11696
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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