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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 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw" update 08/02/2021 the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.
 
Event Description
The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw".Update 08/02/2021: the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.
 
Manufacturer Narrative
The risk assessment of the event, performed during the complaint investigation, concluded on an actual severity of harm of s2, which shall be filed as malfunction as per our procedure.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Due to unknown lot code a dhr review was impossible.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 file will be closed formally in accordance to our procedures.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.
 
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Brand Name
UNKNOWN TARGET DEVICE
Type of Device
INSTRUMENT
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12369748
MDR Text Key268207120
Report Number0009610622-2021-00667
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 Pharmacist
Type of Report Initial,Followup
Report Date 12/22/2021
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 Health Professional
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2021
Initial Date FDA Received08/26/2021
Supplement Dates Manufacturer Received11/24/2021
Supplement Dates FDA Received12/22/2021
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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