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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO, SELF RETAINING PLATE, FIXATION, BONE

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STRYKER GMBH SCREWDRIVER BLADE T10 AO, SELF RETAINING PLATE, FIXATION, BONE Back to Search Results
Catalog Number 703880
Device Problems Positioning Failure (1158); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "variax remover driver's teardrop handle and driver shaft couldn't lock. When the doctor turned the driver down, the driver slipped out. Doctor's comment: please be careful not to ship a broken instrument in the future. Sr recovered the instrument. He was able to wear it with the driver's tip facing up, but when he pointed it down, the driver tip certainly fell out. ".
 
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Brand NameSCREWDRIVER BLADE T10 AO, SELF RETAINING
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10450181
MDR Text Key207315911
Report Number0008031020-2020-02188
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K170727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number703880
Device Lot Number1000349496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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