MAUDE Adverse Event Report: CONMED CORPORATION CONMED/LINVATEC; PASSER

Model Number C6382

Device Problem Break (1069)

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

Event Date 05/07/2019

Event Type  malfunction  

Event Description

Using suture hook, disposable 60 right - with arthroscopic rotator cuff repair surgery.Tip of hook broke off and was retrieved per surgical team.No issues with care provided.

• Brand Name: CONMED/LINVATEC
• Type of Device: PASSER
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 8616528
• MDR Text Key: 145277487
• Report Number: 8616528
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C6382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6935 DA