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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP T2 TIBIA Ø8,+15MM IMPLANT

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STRYKER TRAUMA KIEL END CAP T2 TIBIA Ø8,+15MM IMPLANT Back to Search Results
Catalog Number 18230015S
Device Problems Break (1069); Collapse (1099)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/12/2018
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
The patient underwent t2 tibia surgery on (b)(6) 2017, and the removal surgery was performed on (b)(6) 2018. When the end cap was attempted to be removed with a driver but the head of the end cap collapsed. Therefore, the conical extractor was used to removed the end cap but the tip of the extractor broke in the head of the end cap, and the broken tip could not be removed. The surgeon tried to removed the end cap but it completely stuck in the nail, so only locking screws were removed and the nail removal surgery was gave up. Broken fragment remaining.
 
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Brand NameEND CAP T2 TIBIA Ø8,+15MM
Type of DeviceIMPLANT
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 Key7756162
MDR Text Key116702303
Report Number0009610622-2018-00528
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number18230015S
Device Lot NumberK035F5F
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 Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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