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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Pain (1994)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device discarded.
 
Event Description
The surgeon reported that the patient presented with pain and arthritis in the hip and because of this he undertook revision surgery for removal of a long gamma nail and conversion to a tha. Removal of the nail was a pre-requisite for the tha. The gamma nail had been implanted in approximately 2013. When the patient was opened the surgeon noticed that the most proximal of 2 distal screws was broken. The broken screw had been asymptomatic. The surgeon removed part of the screw, leaving the remaining piece of the screw in the bone. The surgeon did not attempt to remove the remaining piece of the screw. While taking the nail out, the surgeon struggled and tapped the nail. It is unclear whether the remaining screw was catching as the nail was removed. As the nail was removed, the patient sustained stress riser fracture which required an additional plating procedure. This plating resulted in a 2 hour surgical delay. The total delay to surgery was 2. 5 hours. The tha was completed.
 
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Brand NameUNKNOWN GAMMA NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9788533
MDR Text Key193102189
Report Number0009610622-2020-00091
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
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 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
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 Received03/12/2020
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: 03/04/2020 Patient Sequence Number: 1
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