MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S PEEK 5.5MM; ROTATOR CUFF - ARTC

Catalog Number OM-2300

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2015

Event Type  malfunction  

Event Description

It was reported that while completing a procedure using a multifix s peek 5.5mm implant, it was discovered that the tip of the inserter handle was missing.The surgeon was unable to locate the missing tip inside the surgical site, however cannot be confident that it is no longer inside the patient.Otherwise, the procedure was completed successfully without delay and no patient complications have been reported.

Manufacturer Narrative

The customer¿s complaint was verified as the visual inspection shows that device was returned with the die broken, however a root cause could not be determined with certainty.The most plausible cause for the device failure is the user not following the ifu.The instructions for use provided with the device contain warnings and precautionary measures related to proper use of the device including but not limited to: -implantation of this device requires an appropriate level of surgical skill and experience.Surgeons who plan to use this device should carefully review the instructions for use prior to clinical use.Additionally, completion of a skills laboratory and training by the manufacturer or one of its appointed representatives, or observation of/assistance with similar implantation procedures, is recommended.-use care to properly align the implant and inserter handle with the bone hole during pound-in.Avoid excessive probing.-do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.Do not deploy a bent or damaged implant.

• Brand Name: MULTIFIX S PEEK 5.5MM
• Type of Device: ROTATOR CUFF - ARTC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 5148342
• MDR Text Key: 28648629
• Report Number: 3006524618-2015-00531
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K131182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OM-2300
• Device Lot Number: 1072006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1