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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM VA-LCP 2-CLMN VLR DSTL RAD PL 7H HD/3H SHAFT/LT-STER PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM VA-LCP 2-CLMN VLR DSTL RAD PL 7H HD/3H SHAFT/LT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.111.731S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during an unknown procedure, the surgeon was unable to insert the screw into the plate screw hole. No further information provided. This report is for one (1) 2. 4mm va-lcp 2-clmn vlr dstl rad pl 7h hd/3h shaft/lt-ster. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 Name2.4MM VA-LCP 2-CLMN VLR DSTL RAD PL 7H HD/3H SHAFT/LT-STER
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13416901
MDR Text Key284830682
Report Number8030965-2022-00623
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K083694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.111.731S
Device Lot Number220P195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/01/2022 Patient Sequence Number: 1
Treatment
UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: VA LOCKING
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