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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/RIGHT PLATE, FIXATION, BONE

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SYNTHES ELMIRA 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/RIGHT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.118.406
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2017
Event Type  malfunction  
Manufacturer Narrative
Subject device has been received and is currently in the evaluation process. Previous mfr 3003506883-2017-10205, incorrectly reported as two unknown cancellous screws. This is for one (1) va lcp lateral distal fibula plate, part 02. 118. 406, lot 7527668. 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
Additional information indicates the screws would not lock into the plate.
 
Manufacturer Narrative
A product investigation was performed. Following parts were received for investigation. Cortscr ø2. 7 self-tap l10 sst (part # 202. 870, lot # l199338, quantity 1), va-lcp lat dist fibula pl 2. 7 r 6ho l118 (part # 02. 118. 406, lot # 7527668, quantity 1), unknown screw (part # unknown, lot # unknown, quantity 1). Our investigation has shown that the plate has slightly scratches on surface. Furthermore, some threaded holes are damaged. The manufacturing review for does show that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition. Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened. We can only assume that the device was not inserted aligned into the plate. By this the thread flanks got damaged by the screw. Because of the damage the complaint relevant dimensions cannot be checked for dimensional accuracy. Based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances. No product fault could be detected. 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
This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
Patient information not available for reporting. Additional product code: hwc. 510k: this report is for two (2) unknown cancellous screws. Part and lot numbers are unknown; udi number is unknown. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review was completed. Lot 7527668, part number 02. 118. 406, work order (b)(4) (branch plant (b)(4)). A review of the device history record (dhr) for lot 7527668, part number 02. 118. 406 (description: 2. 7mm va-lcp lateral distal fibula plate/ 6 holes/ right), work order (b)(4) revealed zero manufacturing/complaint related anomalies. The documentation reviewed shows that lot 7527668 was processed through normal manufacturing and inspection operations without any confirmed non-conformance's. The dhr evaluation confirms that the lot met all documentation, dimensional, and visual criteria at the time of release with no issues documented that would contribute to this complaint condition. Synthes lot 7385263, part number 14065 (branch plant (b)(4)). A review of the device history record (dhr) for raw material synthes lot 7385263, part number 14065 (description: 316l - fi35. 00x19. 00 raw material) revealed zero manufacturing/complaint related anomalies. The dhr evaluation confirms that the lot met all documentation, dimensional, and visual criteria at the time of release with no issues documented that would contribute to this complaint condition. Date of manufacture (release to warehouse date): 11 november 2013 place of manufacture: synthes usa- (b)(6). 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported during an unknown procedure on (b)(6) 2017, surgeon encountered a problem with the connection between the screwdriver and the screw. Closer review of the devices revealed the screwdriver was fine and the issue was with the 2. 7mm variable angle locking compression plate (va-lcp) lateral distal fibula plate and the two (2) cancellous screws. It was determined the plate is bent and the two (2) screws were cross threaded. Surgery was completed successfully with no delay and no harm to patient. Concomitant device reported: screwdriver (part number unknown, lot number unknown, quantity 1) this report is for one (1) 2. 7mm va lcp lateral distal fibula plate. This is report 2 of 2 for (b)(4).
 
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Brand Name2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/RIGHT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6876648
MDR Text Key251059557
Report Number3003506883-2017-10205
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819520165
UDI-Public(01)07611819520165(10)7527668
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.118.406
Device Lot Number7527668
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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