• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH WRIST FUSION PLATE STRAIGHT VARIAX2 120MM; PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER GMBH WRIST FUSION PLATE STRAIGHT VARIAX2 120MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 629590
Device Problem Break (1069)
Patient Problems Pain (1994); Swelling (2091); Numbness (2415)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
 
Event Description
As reported on medwatch (b)(4) "the patient had a left wrist arthrodesis procedure performed on [.] with autologous bone graft and fixation using a stryker wrist fixation plate.The patient returned for evaluation ~3 years later citing two weeks of increasing left wrist pain and swelling on left dorsal distal forearm and dorsal wrist.The patient also noted numbness of the index, middle and ring finger.An x-ray revealed fracture of the radial metacarpal plate through the screw hole at the carpal metacarpal joint.The patient was taken to the operating room 6 days later for removal of the broken plate and 8 screws.A bone graft was completed.The patient will have a cast for 4-6 weeks and limited lifting capability.There was no patient fall or trauma that could be attributed to the plate fracture.The surgeon thought that the plate breakage was metal fatigue likely due to micromotion of the middle finger (3rd digit) carpometacarpal (cmc) joint.".
 
Event Description
As reported on medwatch (b)(4) "the patient had a left wrist arthrodesis procedure performed on [¿] with autologous bone graft and fixation using a stryker wrist fixation plate.The patient returned for evaluation ~3 years later citing two weeks of increasing left wrist pain and swelling on left dorsal distal forearm and dorsal wrist.The patient also noted numbness of the index, middle and ring finger.An x-ray revealed fracture of the radial metacarpal plate through the screw hole at the carpal metacarpal joint.The patient was taken to the operating room 6 days later for removal of the broken plate and 8 screws.A bone graft was completed.The patient will have a cast for 4-6 weeks and limited lifting capability.There was no patient fall or trauma that could be attributed to the plate fracture.The surgeon thought that the plate breakage was metal fatigue likely due to micromotion of the middle finger (3rd digit) carpometacarpal (cmc) joint.".
 
Manufacturer Narrative
The reported event could be confirmed only based on the x-rays sent.More detailed information about the complaint event (such as the x-rays taken after the placement in the regular follow-up and the x-rays taken directly after the placement of the plate) as well as the affected device must be available in order to determine the root cause of the complaint event.However, with the available information, a partial evaluation was performed.Based on the x-rays sent, the clinical opinion of stryker¿s medical expert about this case states "the plate probably broke after three years due to micro movements in a not healed fusion.The question remains why was there still movement in the fusion-fracture.Did the initial surgery not sufficiently clear the cartilage, so that proper healing could take place? the x-rays suggest that there still is a fracture line visible in the wrist, so it might be that the fusion was never entirely successful and by that micro motion would still be able to occur.Is it just a non-union? and the patient did not suffer from that clinically for three years? this can also be a reason, since sometimes these things happen even if the surgery went flawless.Did the patient have a recent trauma fracturing the fusion fracture and the plate again? this latest option was not described in the information sent.So those options would be possible for the breakage of this plate after three years in my opinion." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WRIST FUSION PLATE STRAIGHT VARIAX2 120MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8732136
MDR Text Key149122533
Report Number0008031020-2019-00729
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327131536
UDI-Public07613327131536
Combination Product (y/n)N
PMA/PMN Number
K151178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number629590
Device Lot Number4002065
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/03/2019
Initial Date FDA Received06/25/2019
Supplement Dates Manufacturer Received08/06/2019
Supplement Dates FDA Received09/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight95
-
-