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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/RT-STER PLATE,FIXATION,BONE

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SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/RT-STER PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.111.630S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery. During the surgery, the surgeon inserted the k-wire into the ulnar side hole of the plate through the guiding block. After that, the surgeon tried to remove the k-wire to correct the placement position of the plate, but k-wire could not be removed from the plate on the operative field (on the body). The surgery was completed successfully within 30minutes delay. No further information is available. This complaint involves two (2) devices. This report is for (1) 2. 4mm ti va-lcp 2-clmn vlr dst rad pl 6h hd/3h shaft/rt-ster. This report is 1 of 2 for (b)(4).
 
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Brand Name2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/RT-STER
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key12510283
MDR Text Key272698900
Report Number8030965-2021-07916
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K083694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.111.630S
Device Lot Number96P9930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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