MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MOD TRINKLE REAMING ATTACHMENT F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.783

Device Problem Fitting Problem (2183)

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

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported that during an unspecified knee surgery, it was observed that the attachment device would not seat or secure the burr device.There were no delays to the surgical procedure as an identical spare device was available to successfully complete the procedure.There was patient involvement reported.There were 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

Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the tool coupling components were worn and did not allow attachment of the burr or the function gauge.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear on components from repeated use over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The initial report stated "there were reports of injuries, medical intervention or prolonged hospitalization." incorrectly.The event description has been updated to reflect that it was reported that there were no injuries, medical intervention or prolonged hospitalization.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: MOD TRINKLE REAMING ATTACHMENT F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 4731329
• MDR Text Key: 21771125
• Report Number: 3009450871-2015-11336
• Device Sequence Number: 1
• Product Code: GEY
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.783
• Device Lot Number: 8371256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1