MAUDE Adverse Event Report: SYNTHES BRANDYWINE LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

Catalog Number 04.632.000

Device Problems Difficult To Position (1467); Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: during a procedure on an unknown date the matrix locking cap construct jammed.Torque limiter optional techniques were tried to loosen the closure caps, but it was unsuccessful.The closure cap could not be moved.This is report 2 of 6 for this (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional codes mnh, mni, kwq, kwp.A review of the device history record revealed no complaint related anomalies.An additional evaluation was performed on the returned product.An update of the surgical technique, with different options for loosening a locking cap has been addressed.A new type of locking cap has been introduced, which has an improved opening behavior after final tightening.Placeholder.

• Brand Name: LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4346649
• MDR Text Key: 5206262
• Report Number: 2530088-2014-00157
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.000
• Device Lot Number: 6993511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2012
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1