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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE INSTRUMENT

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STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
As reported; "the patient broke their hip. The target is missing the nail. The nail did not get locked distally, the surgery was completed successfully. No patient impact. 3-5 minutes surgical delay. No adverse consequences. ".
 
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition is unknown.
 
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Brand NameUNKNOWN TARGET DEVICE
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12802289
MDR Text Key281739147
Report Number0009610622-2021-00786
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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