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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ASNIS III WASHER (5.0 MM); IMPLANT

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STRYKER GMBH UNKNOWN ASNIS III WASHER (5.0 MM); IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/01/2004
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6).The title of this report is ¿clinical and radiological outcomes of arthroscopically assisted cannulated screw fixation for tibial eminence fracture in children and adolescents¿ which is associated with the stryker ¿asnis iii cannulated screw¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 2004 to (b)(6) 2015.It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 13 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses instability of the knee.The report states: ¿the mean lysholm knee score was 94.8 ± 6.8 (range, 78 to 100) at the latest follow-up.The score was more than 90 in 18 (82%) patients, 80 to 90 in 3 (14%) patients, and 78 in 1 (5%) patient who showed instability of the knee in physical examination and kt-1000 arthrometer measurement.¿.
 
Event Description
The manufacturer became aware of a study from seoul national university college of medicine, republic of korea.The title of this report is ¿clinical and radiological outcomes of arthroscopically assisted cannulated screw fixation for tibial eminence fracture in children and adolescents¿ which is associated with the stryker ¿asnis iii cannulated screw¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from may 2004 to august 2015.It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 13 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses instability of the knee.The report states: ¿the mean lysholm knee score was 94.8 ± 6.8 (range, 78 to 100) at the latest follow-up.The score was more than 90 in 18 (82%) patients, 80 to 90 in 3 (14%) patients, and 78 in 1 (5%) patient who showed instability of the knee in physical examination and kt-1000 arthrometer measurement.¿.
 
Manufacturer Narrative
New information in section h6 (device code and patient code).
 
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Brand Name
UNKNOWN ASNIS III WASHER (5.0 MM)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9397517
MDR Text Key185223827
Report Number0008031020-2019-02019
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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