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

Catalog Number 357.371

Device Problem Fitting Problem (2183)

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

Event Date 04/30/2016

Event Type  malfunction  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Dhr review part number: 357.371 synthes, lot number: 7681977, release to warehouse date: (b)(6) 2014, supplier: (b)(6), ncr # (b)(4) was generated during production for bag separation at perforation and parts were reworked as needed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a trochanteric fixation nailing procedure (tfn) on (b)(6), 2016 for intertrochanteric fracture, the compression nut got jammed on the sleeve during assembly of the instruments and would not slide through the sleeve.It was reported, surgeon was able to disengage the nut from the sleeve after multiple attempts.A back up nut and same sleeve was used to complete the procedure successfully.A two (2) minutes surgical delay was reported and patient/status was reported as "fine".Additionally, it was reported that, burs were noticed on the threads of the blade guide sleeve.This complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the returned 357.369 lot number 4611680 blade guide sleeve and the 357.371 lot number 7681977 buttress/compression nut show signs of heavy use and several scrape markings but nothing that would impair their function.The devices function together as designed.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 devices were reported to have become jammed together during surgery.This complaint is unconfirmed.The complaint condition cannot be replicated.The devices were received disassembled from one another and the buttress/compression nut advances down the blade guide sleeve with negligible resistance.No burrs were detected in the threading of the blade guide sleeve.No design issue was found during the investigation of the 357.369 blade guide sleeve and 357.371 buttress/compression nut and therefore review to the applicable dcrm is not required.The devices were reported to have become jammed together during surgery.This complaint is unconfirmed.The complaint condition cannot be replicated.The devices were received disassembled from one another and the buttress/compression nut advances down the blade guide sleeve with negligible resistance.Device history records was conducted.The report indicates that the: dhr review part number: 357.371 synthes lot number: 7681977 release to warehouse date: (b)(6) 2014 supplier: (b)(4).Ncr # (b)(4) was generated during production for bag separation at perforation and parts were reworked as needed.This non-conformance is not relevant to the complaint condition since bag separation at perforation would not impact the complaint condition of the compression nut getting jammed on the sleeve.Review of the device history record(s) showed that there were no issues during the manufacture of the 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.

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5659498
• MDR Text Key: 45312246
• Report Number: 1719045-2016-10406
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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: 7681977
• Other Device ID Number: (01)10886982196057(10)7681977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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
• Patient Age: 77 YR
• Patient Weight: 61