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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 TARGET DEVICE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 TARGET DEVICE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES 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 03/27/2022
Event Type  malfunction  
Event Description
The customer reported that "when locking the distal screw, it is impossible to chew in the nail hole (dynamic and static). The screw goes under the nail (ancillary checked before). Impossible to lock the nail (screwing under the nail
=
ineffective)". Additional information received: the 2nd nail was placed and left in place despite the poor positioning of the distal screw. The procedure was delayed by 60 min.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
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Brand NameUNKNOWN GAMMA 3 TARGET DEVICE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14192296
MDR Text Key289956371
Report Number0009610622-2022-00149
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No
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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