MAUDE Adverse Event Report: SYNTHES BRANDYWINE LARGE BUTTRESS/COMPRESSION NUTFOR BLADE GUIDE SLEEVE TFN; TRACTION,APPARATUS,NON-POWERED

Catalog Number SD357.371

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 08/28/2012

Event Type  malfunction  

Event Description

It was reported that, during a tfn procedure, the surgeon encountered problems with four (4) instruments.The end piece on the gold handle of the helical blade inserter falls off and does not hold.The blade guide sleeve and the large buttress/compression nut are difficult to thread together.The two devices also becomes stuck together when threaded and is difficult to disassemble.The aiming arm does not lock onto the blade guide sleeve and allowing the sleeve to slide.Surgeon did complete the procedure with no adverse effect to the patient.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device used for treatment, not diagnosis.Device history was reviewed and not issues were found.Subject device was received in fair condition.The holes around the outer profile show signs of wear and are elongated.The internal threads only show minor wear.Threads were checked and gauge threaded properly.No issues could be found.Placeholder.

• Brand Name: LARGE BUTTRESS/COMPRESSION NUTFOR BLADE GUIDE SLEEVE TFN
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• 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: 4346468
• MDR Text Key: 16451881
• Report Number: 2530088-2014-00062
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/28/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: SD357.371
• Device Lot Number: 6841538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR