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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT 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 Date 04/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Device is an instrument and is not implanted/explanted. Part 357. 371, lot 6289832: release to warehouse date: march 26, 2010. 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. 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, that an (b)(6) female patient had an initial open reduction internal fixation (orif) of a right hip fracture on (b)(6) 2016. During the procedure the clip that keeps the aiming arm in place was worn and would not hold and it did not get adequate compression. The buttress compression nut that is married to the aiming arm was not holding properly. There was no patient harm and only a two minute surgical delay. The procedure was completed successfully. This is report 2 of 2 for (b)(4).

 
Manufacturer Narrative

Product investigation summary: one (1) 130 degree aiming arm body (part 357. 366 / lot 3371386) and one (1) buttress compression nut (part 357. 371 / lot 6289832) were received for investigation. Both devices are extremely worn with scratches and marks in numerous locations. The aiming arm is also missing three of the four pins that affix the gold collar to the device. The devices were tested/assembled with known conforming instrumentation to test the locking mechanism of the aiming arm; no issues or discrepancies were detected. The aiming arm and compression nut functioned as intended. This complaint is unconfirmed. The exact cause for the complaint condition is unknown. A visual inspection, functional test, and drawing review were performed as part of this investigation. The current drawing for each device was reviewed. No drawing issues or discrepancies were noted. The instruments were tested with known conforming devices. The devices functioned as intended with no slippage or loss of fixation. 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. No manufacturing issues were noted and no design issues were found with the current design during the investigation. The design is determined to be adequate for its intended use when used and maintained as recommended. Device 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 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 Key5582109
Report Number1719045-2016-10325
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number6289832
OTHER Device ID Number(01)10886982196057(10)6289832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2010
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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