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

Catalog Number 357.371

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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

It was reported that a patient underwent a hip fracture procedure on (b)(6) 2017.During the surgery, the buttress/compression nut kept popping off the blade guide sleeve and wouldn¿t stay locked.The surgery was successfully completed with no delay or patient harm.Concomitant device reported: blade guide sleeve for trochanteric fixation nails (part number 357.369, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and 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.

Event Description

The buttress nut was popping off of the aiming arm, not the blade guide sleeve.Additional concomitant device reported: aiming arm (part/lot unknown, quantity 1).

Manufacturer Narrative

Dhr review for part # 357.371, supplier lot # 7434744.No ncrs 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.Release to warehouse date: 20-sep-2013.Supplier: (b)(4).An evaluation was performed on the returned device.The following complaint device was received by customer quality (cq): under (b)(4); one (1) buttress/compression nut p/n 357.371, lot# 7434744.A visual inspection, functional test, dhr review, technique guide review and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.There were no new issues identified for the returned product outside the complaint.Damage to the od dimension of the protruding feature of the nut (neck) that locks with the aiming arm was confirmed during visual inspection.The feature was observed to be uniformly deformed to a small extent.This could have happened due to exposure to intra-operative forces throughout the service life of the device or incorrect technique.No damage on the threads of the device was observed.The overall balance of the returned complaint device is in fair condition with minimal wear and tear.Additionally, in the product pictures provided by the sales consultant a tape with characters ¿spi¿ was observed on the complaint device.It is unclear if the tape was on the device during operation, but this poses a potential assembly and technique issue.Buttress nut is a device with very fine assembly tolerances, the observed tape of unknown thickness could have compromised the overall fitting of the two components.The functional test was performed using guide sleeve and an aiming arm known to be in a good condition.The buttress nut could assemble with the aiming arm as per expectation and did not pop out of the aiming arm when the force was applied.The buttress nut would only dissemble from the aiming arm with the help of a release button.Hence, the complaint condition was partially replicated at the cq location as the concomitant devices were not returned and not all unknown intra-operative forces could be simulated during the functional test.The other mating parts used during the surgery such as guide sleeve or aiming arm which could have contributed to the complaint condition were not returned with the complaint for the investigation purpose.No definitive root cause was able to be determined with the given details.Possible root causes such as improper technique or other mating parts used during the surgery could have contributed to the complaint issue.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6534053
• MDR Text Key: 74161938
• Report Number: 1719045-2017-10365
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• 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: 7434744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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