MAUDE Adverse Event Report: ARTHROCARE CORPORATION ARTHROCARE; SPEEDSCREW 5.5 MM PEEK KNOTLESS FIXATION IMPLANT

Lot Number 1096429

Device Problems Break (1069); Failure to Advance (2524); Failure to Disconnect (2541)

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

Event Date 09/09/2015

Event Type  malfunction  

Event Description

Speedscrew 5.5mm peek knotless fixation implant.Three of these were attempted to be implanted and broke while in the pt.All three had the same lot number however had different problems.The first did not disengage, the second did not pass the suture and the third broke off needle.

• Brand Name: ARTHROCARE
• Type of Device: SPEEDSCREW 5.5 MM PEEK KNOTLESS FIXATION IMPLANT
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 5124224
• MDR Text Key: 27461465
• Report Number: MW5056771
• Device Sequence Number: 1
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2018
• Device Lot Number: 1096429
• Other Device ID Number: OM-6500
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR