MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S PEEK 5.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number OM-2300

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/08/2016

Event Type  Injury  

Event Description

It was reported that approximately four months after a shoulder procedure using a multifix s peek 5.5mm anchor, the anchor had backed out of the bone and was floating loose in the shoulder.This deficiency resulted in a revision surgery.The failed implant was removed with graspers, scar tissue was removed and the rotator cuff was successfully re-repaired using another implant.No additional complications have been reported as a result of this procedure.

Manufacturer Narrative

The subject multifix s implant was used for repair and returned for evaluation.Only the implant was returned.Relationship between the reported incident and returned device was not established.The multifix s inserter handle was not returned for evaluation.The anchor body and sleeve were returned for evaluation.Blue and cobraid magnumwire and a blue unidentified suture were found properly snared on the anchor.Per complaint description, the anchor pulled out from place post-surgery.The complaint was verified, but the root cause for the the anchor pulled out from place post-surgery could not be determined with confidence.Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: poor bone quality.Use of suture other than qualified #2 magnumwire, ultrabraid, and ultratape sutures.The instruction for use (ifu) outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The ifu contraindicates the use of this device in poor bone quality as implant pull out may occur and the use of suture other than #2 magnumwire, ultrabraid, and ultratape sutures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MULTIFIX S PEEK 5.5MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 5901575
• MDR Text Key: 52947939
• Report Number: 3006524618-2016-00221
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OM-2300
• Device Lot Number: 1123849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR