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U.S. Department of Health and Human Services

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

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SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problem Failure To Adhere Or Bond
Event Type  Malfunction  
Manufacturer Narrative

Device is an instrument and is not implanted/explanted. Part 357. 371, lot 4436455: release to warehouse date: november 05, 2002. Manufactured at synthes (b)(4) facility. 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. 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

It was reported during an inspection, a buttress compression nut and a 130 degree aiming arm for trochanteric fixation nail (tfn) appear to be worn. The aiming arm has a spring that holds the buttress compression nut and the guide sleeve in place, but the spring in the aiming is weak and will not hold the buttress compression nut. There was no surgical delay as this complaint did not involve a patient. This is report 1 of 2 for (b)(4).

 
Manufacturer Narrative

A product investigation was completed: the devices were received for investigation. All devices are intact and with cosmetic damage consistent with regular use in the field. Part 357. 366, lot 3664087 and part 357. 371, lot 4436455 were assembled together with a known conforming part 357. 369 and the returned complaint parts functioned as designed. All returned parts were found to function as intended when assembled to the correct mating parts. The cause of the complaint condition could not be determined. This complaint is unconfirmed. The instrument(s) are used during implantation of titanium femoral nails and proper use and maintenance are addressed in the technique guides. The returned devices are multi use and are used for implanting nails. The relevant drawings were reviewed. No drawing issues or discrepancies were noted. The designs are adequate for their intended use and did not contribute to this complaint condition. A review of the device history records 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.

 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
Type of DeviceTRACTION, 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
6107195000
MDR Report Key5526172
Report Number2530088-2016-10091
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Device Catalogue Number357.371
Device LOT Number4436455
OTHER Device ID Number(01)10886982196057(10)4436455
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/05/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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