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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEFT,SHORT, 11 HOLES; PLATE, FIXATION, BONE

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STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEFT,SHORT, 11 HOLES; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 54-25376S
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Implanting of the plate using variaxdr with left radial distal end fracture osteosynthesis.When confirming with the image before the suture, since it was two pieces remained like metal pieces near the proximity from the plate installation position, it was collected out of patient body.Checked the variaxdr's instruments and drills used in the ope, but not find the instrument damage.It was confirmed that the tip of the hospital-owned kochel forceps is missing, but can not specify whether this is kochel forceps or implant fragments.
 
Event Description
Implanting of the plate using variaxdr with left radial distal end fracture osteosynthesis.When confirming with the image before the suture, since it was two pieces remained like metal pieces near the proximity from the plate installation position, it was collected out of patient body.Checked the variaxdr's instruments and drills used in the ope, but not find the instrument damage.It was confirmed that the tip of the hospital-owned kochel forceps is missing, but can not specify whether this is kochel forceps or implant fragments.
 
Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.Note that plate is still implanted and forceps which is actually broken off is not even a stryker product at all.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
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Brand Name
VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEFT,SHORT, 11 HOLES
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8081327
MDR Text Key127861611
Report Number0008031020-2018-00984
Device Sequence Number1
Product Code HRS
UDI-Device Identifier04546540578693
UDI-Public04546540578693
Combination Product (y/n)N
PMA/PMN Number
K040022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number54-25376S
Device Lot Number1000304772
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/23/2018
Initial Date FDA Received11/16/2018
Supplement Dates Manufacturer Received11/22/2018
Supplement Dates FDA Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age81 YR
Patient Weight73
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