MAUDE Adverse Event Report: SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Catalog Number 357.371

Device Problem Mechanical Jam (2983)

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

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No patient information reported.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Event Description

It was reported that during a trochanteric fixation nail (tfn) procedure on (b)(6) 2016 for a right intertrochanteric fracture, the surgeon was unable to get the buttress nut to release.Therefore, his ability to remove the helical blade sleeve was impeded.There was a 10 to 15 minute surgical delay while the surgeon unscrewed the knob on the aiming arm to get the device apart.The remainder of the surgery went as planned and the patient was reported as stable.It was noted that when the operating room technician looked at the device on the back table, there was not a problem with releasing the buttress nut.Concomitant devices: aiming arm (part #357.366, lot #unknown, quantity 1).Helical blade guide sleeve (part #357.369, lot #unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Part 357.371, lot 5519090: release to warehouse date: july 10, 2007.Supplier: (b)(4).No non-conformance reports were generated during production; review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices: aiming arm (part 357.366, lot 5545207, quantity 1); helical blade guide sleeve (part 357.369, lot 5512256, quantity 1).

Manufacturer Narrative

A product development investigation was performed for the subject device buttress/compression nut (part # 357.371, lot # 5519090).The returned 357.371 lot number 5519090 buttress/compression nut shows very few signs of wear and nothing that would impair its function.The device functions as designed.The returned 357.369 lot number 5512256 blade guide sleeve and 357.366 lot number 5545207 aiming arm were received without allegation or identifiable complaint condition and therefore an investigation will not be performed for these parts.A visual inspection, dimensional inspection, drawing review, and dhr review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The device was reported to not release from the returned concomitant parts.This complaint is unconfirmed.The complaint condition cannot be replicated.The device assembles and disassembles without difficulty.No design issue was found during the investigation of the 357.371 buttress/compression nut.There were no issues found with the returned device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5967180
• MDR Text Key: 55272478
• Report Number: 2520274-2016-14615
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Device Lot Number: 5519090
• Other Device ID Number: (01)10886982196057(10)5519090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AIMING ARM (PART #357.366, LOT #UNKNOWN, QTY 1; BLADE GUIDE SLEEVE (PART #357.369, LOT #UNK QTY 1