MAUDE Adverse Event Report: MANSFIELD MANUFACTURING SITE BIOSURE - PK; BIOSURE PK, 9 X 25MM

Model Number 72202272

Device Problem Device Issue (2379)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

It was reported that the patient experienced post-operative discomfort at the initial surgical site.The biosure pk screw backed out of the sync device and was sitting in the patient¿s soft tissue (anterior tibia).The screw was removed from the patient.The sync device remained in the tibial canal but was removed in pieces with a rongeur.Patient¿s bone quality was reported as ¿good¿.Tunnel size was 9mm.Size dilator used 9-10.Screw and sync were implanted roughly 6 months prior to revision.The tunnel was packed with allograft cancellous chips to revise the repair.No patient injury or complications were reported upon completion of the revision surgery.

Manufacturer Narrative

No product is being returned for analysis.(b)(4).

Manufacturer Narrative

One biosure pk screw was returned for evaluation.Visual examination of the screw showed the distal threads are rolled over.Dimensional inspection confirmed the major diameter and length to be within print specification.In addition the biosure sync device used with the screw was also returned for evaluation.The sync was broken in four pieces and one of the wings was not returned.No root cause related to the manufacture of the product can be determined.No further investigation is warranted at this time.(b)(4).

• Brand Name: BIOSURE - PK
• Type of Device: BIOSURE PK, 9 X 25MM
• 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: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3613624
• MDR Text Key: 18811858
• Report Number: 1219602-2014-00033
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 72202272
• Device Catalogue Number: 72202272
• Device Lot Number: 50477153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Required Intervention