MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE TWINFIX ULTRA - TI; TWINFIX TI 5.0 ULTRABRAID

Model Number 72200755

Device Problem Device Issue (2379)

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

Event Date 10/16/2013

Event Type  malfunction  

Event Description

During an acl (anterior cruciate ligament) repair procedure utilizing a twinfix ti 5.0 ultrabraid, it was reported that the anchor broke.A second site was prepared and the surgeon inserted another anchor, leaving the initial site empty.There were no reports of patient injuries or complications.

Manufacturer Narrative

The device was marked as available for evaluation; although anticipated, the device has not yet been received.(b)(4).

Manufacturer Narrative

Device evaluation: only the titanium anchor was returned for evaluation.It presented with bone material embedded in the threads.All of the threads have visible damage with the worst being at the proximal end where force was required to remove the device.The damage sustained is indicative of hard bone being encountered.The patient¿s bone quality was reported as unknown.Due to these observations no root cause related to the manufacturing process can be established.A review of the device history records was performed which confirmed no inconsistencies.No further investigation is warranted at this time.The instructions for use states: ¿using the appropriate smith & nephew drill bit and drill guide (each sold separately), prepare the anchor insertion site (refer to the use of smith & nephew drill bits and drill guide sections of this document).Either predrilling or use of a punch type device is recommended for site preparation, depending on the bone quality.Predrilling is recommended if the quality of the bone is unknown.¿ (b)(4).

• Brand Name: TWINFIX ULTRA - TI
• Type of Device: TWINFIX TI 5.0 ULTRABRAID
• Manufacturer (Section D): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): MANSFIELD MANUFACTURING SITE; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jason bilobram ; 150 minuteman road; andover, MA 01810 ; 9787491630
• MDR Report Key: 3598943
• MDR Text Key: 4166077
• Report Number: 1219602-2014-00028
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 50457383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2013
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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 Age: 29 YR