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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE FOR T2 FEMUR NAIL INSTRUMENT

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STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE FOR T2 FEMUR NAIL INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Misassembled (1398)
Patient Problem No Code Available (3191)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
Head of traumatological-orthopaedics surgery ward informed that screws locking the nail in the proximal part were screwed in outside of holes despite of use of targeting device - being a part of t2 femur instrument kit, which was inspected before the surgery. As per the customer after assembly of the targeting device with the nail, through the holes in the arm of targeting device sleeves were introduced and personnel checked correctness of calibration of the holes in the targeting device and in the nail and confirmed that it was in order. During control visit, after a few days customer discovered that the screws were screwed in outside of the nail and revision surgery was needed. Another t2 femur kit (new, unused) was sent to the customer to facilitate the surgery. According to customer, the nail which was already implanted were moved deeper in order to avoid screwing in the screws in the holes already prepared during initial surgery. According to customer, situation repeated - despite of the use of targeting device following its inspection of usability, the screws were introduced next to the nail.
 
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Brand NameUNKNOWN TARGET DEVICE FOR T2 FEMUR NAIL
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6896130
MDR Text Key87453811
Report Number0009610622-2017-00300
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2017
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 Treatment Data
Date Received: 09/26/2017 Patient Sequence Number: 1
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