MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JGRKNT LONG 1 #2 BLUE MB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/07/2014

Event Type  Injury  

Event Description

It was reported patient underwent a hip scope on (b)(6) 2014.During the procedure the suture anchors would not remain implanted.The surgeon drilled additional holes to complete the procedure using competitor anchors.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: number 2 states, ¿ improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure.¿ number 4 states, ¿failure to achieve adequate fixation or improper positioning or placement of the device can contribute to a subsequent undesirable result.¿ evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-05160 / 05161).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.The root cause of the event was determined to likely be due to improper hole preparation.

• Brand Name: JGRKNT LONG 1 #2 BLUE MB
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3845626
• MDR Text Key: 4406027
• Report Number: 0001825034-2014-05160
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 010000324
• Device Lot Number: 899200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention