MAUDE Adverse Event Report: SYNTHES MONUMENT 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 09/27/2015

Event Type  malfunction  

Manufacturer Narrative

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.(b)(6).Without a valid 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.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

Device report from synthes (b)(4) reported a helical blade coupling screw broke during a proximal femoral fracture.The proximal end of the coupling screw broke as the surgeon was hammering in the helical blade; both pieces were accounted for; no fragments were generated, and none of the pieces fell into the patient.As a result of the coupling screw breaking, it was necessary to mallet on the blade guide sleeve and the buttress/compression nut to back out the helical blade thus, disconnecting the broken connecting screw.Both parts were damaged beyond repair.The surgeon successfully removed the helical blade from the broken helical blade coupling screw, prior to inserting a new one.There was no reported harm to the patient.There was no surgical delay reported.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Device history record review for part 357.371, synthes lot 6064459/supplier lot ti01759: release to warehouse date: 15january2009.Supplier- troutman industries inc.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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that:the complaint condition for the 357.377 lot number 6606044 helical blade coupling screw, 357.371 lot number ti01759 buttress/compression nut, and 357.369 lot number 6320172 blade guide sleeve was likely caused by excessive and off angle malleting during surgery; however, this complaint is not likely a result of any design related deficiency.It is likely that the inner threading of the buttress/compression nut or the threading of the blade guide sleeve has become deformed causing the devices to stick together leading to this complaint condition.No product issue was alleged or identified upon examination of the returned 357.372 lot number 6510303 helical blade inserter.This investigation summary is approved.Lot number discovered to be ti01759, was the correct, valid lot number.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.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5135543
• MDR Text Key: 27824394
• Report Number: 2520274-2015-16496
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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: TI01759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1