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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 Problems Failure To Adhere Or Bond; Device Operates Differently Than Expected
Event Date 03/02/2015
Event Type  Malfunction  
Event Description

It was reported that a nail broke at the hole for a helical blade. The patient had previously undergone a trochanteric fixation nail (tfn) procedure (date unknown) to address a sub-trochanteric fracture. The patient then experienced a non-union. A revision procedure occurred on (b)(6) 2015, during which the im nail, helical blade, and two (2) distal interlocking 5mm screws were removed. The surgeon reported that the 130 degree aiming arm used during this procedure was not interfacing with a compression nut. The surgeon further described the arm as ¿popping out. ¿ no further information was provided. This report is 6 of 6 for (b)(4).

 
Manufacturer Narrative

Patient date of birth, gender, and weight are unknown. Device is an instrument and is not implanted or explanted. It is unknown if the complainant part will be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn as no product was received. A review of the device history records has been requested. 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.

 
Manufacturer Narrative

Subject device has been received and an investigation summary was performed. The investigation of the complaint articles has shown that: the buttress/compression nut, and the 130° aiming arm are components of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures. The technique guide was reviewed for proper use of the instrumentation for this system (j3900-i). One buttress/compression nut (part# 357. 371, lot# 4820011, mfg aug2004, and one 130° aiming arm (part# 357. 366, lot# 8070897, mfg oct2012) were returned with the complaint that ¿patient underwent revision surgery on march 2, 2015 for hardware removal including the im nail (part number 456. 419 and lot number 7394625), helical blade (part number 456. 303 and lot number 6922070, and 2 distal interlocking 5 mm screws (part numbers 458. 944 and 458. 946). It was also reported that a 130 degree aiming arm (part number 357. 366, lot number 8070897) was not interfacing, further described as popping out, with a compression nut (part number 357. 371 and lot number 4820011), during the revision surgery. ¿ upon receipt of these devices it was seen that there is a high degree of wear at the nut: aiming arm interface, and when the aiming arm is mated with the blade guide sleeve and the buttress/compression nut, it forms a very loose connection, and with the application of minimal force the junction may separate, this complaint is confirmed. The designs of these devices are appropriate for their intended uses and did not 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

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

The review of the original device history record showed a material review record (mrr) for clarify and correctness. (b)(4). The nonconformities documented on mrr are unrelated to the complaint condition as the entire lot was found conforming to specifications. There were no other relevant issues during manufacturing which could have caused or contributed to this complaint. 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

Device was used for treatment, not diagnosis. Additional narrative: the previously reported (medwatch follow up #2) investigation results were submitted prematurely and before the investigation were completed and reviewed by engineering. The following contains the final results summary: a product development investigation was performed for the subject device (part number 357. 371, lot number 4820011, buttress/compression nut). The buttress/compression nut (subject device), and the 130 degree aiming arm are components of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures. The technique guide was reviewed for proper use of the instrumentation for this system. The subject device was returned with the complaint that ¿patient underwent revision surgery on (b)(6) 2015 for hardware removal including the im nail (part number 456. 419 and lot number 7394625), helical blade (part number 456. 303 and lot number 6922070, and 2 distal interlocking 5 mm screws (part numbers 458. 944 and 458. 946). It was also reported that a 130 degree aiming arm (part number 357. 366, lot number 8070897) was not interfacing, further described as popping out, with a compression nut (part number 357. 371 and lot number 4820011), during the revision surgery. ¿ upon receipt of these devices it was seen that there is a high degree of wear at the nut/aiming arm interface, and when the aiming arm is mated with the blade guide sleeve and the buttress/compression nut, it forms a very loose connection, and with the application of minimal force the junction may separate, this complaint is confirmed. The drawing for the buttress/compression nut was reviewed and the design, material and finishing process was seen to be adequate for its intended use, and the received part is dimensionally compliant. A review of the device history records for part number 357. 371, lot number 4820011 indicated there were no other relevant issues during manufacturing which could have caused or contributed to this complaint. (as previously reported). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

The date received by manufacturer for medwatch follow ups #3 and #4 should have been may 20, 2015 and was reported in error as june 11, 2015. 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 Key4593810
Report Number2530088-2015-10085
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number4820011
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/11/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received05/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2004
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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