MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR BIOCOMPO- SITE PUSHLOCK 2.9X15.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-1923BC

Device Problem Noise, Audible (3273)

Patient Problems Laceration(s) (1946); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)

Event Date 04/15/2014

Event Type  Injury  

Event Description

It was reported that the patient had left shoulder procedure on (b)(6) 2012.An arthroscopic left reverse bankart repair and a bicep tenotomy with a mini-open biceps tenodesis.Within 6 weeks after surgery, the patient reported to have a great deal of pain, range of motion restrictions, and a very loud crunching and grinding noise.The patient went for a second opinion.It was revealed that the cartilage deteriorated rapidly and within several months post-surgery, the diagnosis was chondrolysis and the patient was told he needed a total shoulder replacement.The second surgeon found multiple proud anchors and at least two anchors that were placed not on the rim of the glenoid, but more towards the center and middle of the glenoid.Surgeon does not believe that the anchors migrated from their original placement.The patient had the total shoulder replacement in (b)(6) 2014.Follow-up investigation: the 7 implants may have only become proud or had the appearance of being proud due to the cartilage deteriorating.The 2nd surgeon does not believe the implants had migrated from their original placement.The post-op report states: pan labral tear circumferential around the glenoid.At the most pronounced posterior aspect of the glenoid, there was evidence of full thickness chondral loss at the edge of this structure as well as on the central posterior humeral head.The deterioration of cartilage may have contributed to the need for a shoulder replacement.

Manufacturer Narrative

Patient demographics ( weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the devices were not returned for evaluation.The cause of the patient having a revision surgery and a total shoulder replacement could not be determined from the information available and without device evaluation.A most likely cause of the event may be as stated in the report: it was revealed that the cartilage deteriorated rapidly and within several months of post-surgery, the diagnosis was chondrolysis and the patient was told he needed a total shoulder replacement.The implants may have only become proud or had the appearance of being proud due to the cartilage deteriorating.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device unknown device disposition.

• Brand Name: SUTURE ANCHOR BIOCOMPO- SITE PUSHLOCK 2.9X15.5MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4322295
• MDR Text Key: 15121508
• Report Number: 1220246-2014-00248
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2014
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 591305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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
• Treatment: AR-1923BC, BIO-COMP ANCHOR, PUSHLOCK, LOT 557119.
• Patient Outcome(s): Other
• Patient Age: 36 YR