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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.111.531S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
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, the patient underwent an unknown surgery with the va-lcp two-column volar distal radius plate for the fracture of the distal radius. The surgeon drilled proximally the second hole of the plate from the distal radius side with the sleeve. When the surgeon inserted the va locking screw, it was not locked. The surgeon failed to remove the screw. The surgery was completed without removing the screw. No further information is available. This report is for one (1) 2. 4mm ti va-lcp 2-col dstl rad pl nrw 6h hd/3h shaft/lt-ster. This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Additional narrative: initial reporter is synthes sales representative product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot: part # 04. 111. 531s. Lot # 440p201. Manufacturing site: (b)(4). Release to warehouse date: 05 nov 2021. Expiration date: 01 oct. 2031. A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified. 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 TI VA-LCP 2-COL DSTL RAD PL NRW 6H 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 MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13653557
MDR Text Key289288154
Report Number8030965-2022-01291
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.111.531S
Device Lot Number440P201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/02/2022 Patient Sequence Number: 1
Treatment
UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: VA LOCKING
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