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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Patient Problems Pain (1994); Disability (2371); Device Embedded In Tissue or Plaque (3165)
Event Date 09/12/2016
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
It was reported via fda medsun report 4501350000-2016-8005: during a surgical attempt for removal of existing hardware from a patient's right im canal, a small tip of the hook of the stryker vendor instrument designed to facilitate removal broke off and lodged in the im canal. It was determined it would be best to leave the broken tip in the bone. The size was approximately 2mm. There was not immediate or long term anticipated negative effects for the patient. Removal of a broken distal interlock screw through a gamma nail. Additional information: about 2 years ago, this (b)(6) male suffered a subtrochanteric femur fracture, was treated by cephalomedullary nailing at an outside hospital. During followup, distal interlock broke, followed by the nail itself breaking. The patient continued to suffer pain, disability. Went back to his original surgeon, who recommended he seek out an orthopedic traumatologist for evaluation and treatment. Was interviewed and examined in my private office, and after lengthy discussion about risks and benefits of surgical versus nonsurgical treatment, to include death and prolonged disability, the patient elected for operative management of his injury. Informed consent was obtained.
 
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Brand NameUNKNOWN NAIL
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 Key6042446
MDR Text Key57917732
Report Number0009610622-2016-00479
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 Risk Manager
Type of Report Initial
Report Date 09/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/19/2016 Patient Sequence Number: 1
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