MAUDE Adverse Event Report: STRYKER ENDOSCOPY TOMCAT; BLADE, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 375-545-000

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/02/2015

Event Type  malfunction  

Event Description

The pt had an acl repair done.At the pt's post-op visit, it was noticed on x-ray that a portion of the shaver tip had broken off and was retained in the pt's left knee.The dr took him back to surgery for a knee arthroscopy with foreign body removal/left.Dr was able to locate the retained foreign body and it was sent to pathology for gross examination with special instructions to save to be sent back to manufacturer.Pictures were also taken with the arthroscopic camera.Patient safety also called during the case and she was informed of the plan of action.She agreed that all appropriate measures were being taken during an left knee aclr, a piece of the stryker tomcat shaver blade from the 4.5 mm resector blade (approx.4-5 mm long) broke off in the fat pad of the anterior knee region, probably not in the intra-articular space.It was not apparent during the case that this happened.It was identified on the clinic x-ray.Surgery is scheduled for removal of foreign body.Manufacturer response for stryker formula tomcat cutter (red/white) 4mm, tomcat (per site reporter): replaced all inventory of the surgery center's 4.0mm tomcat resector blades and credited the one used in the case.Returned to manufacturer.

• Brand Name: TOMCAT
• Type of Device: BLADE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 5390299
• MDR Text Key: 36807999
• Report Number: 5390299
• Device Sequence Number: 0
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 375-545-000
• Device Lot Number: UNAVAILABLE
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Event Location: Other
• Date Report to Manufacturer: 11/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, THIS WAS NOT APPARENT DURING THE CASE OF
• Patient Age: 18 YR