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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA NAIL - LEFT IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Bent (1059)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 12/15/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. The patients family kept implant.
 
Event Description
Locking screw was broken but was left in the patient. According to the doctor there was a terrible bond causing the gamma nail to break. The number one complaint was pain due to the nail being broken. The patient was revised due to a hemiarthroplasty. Left hip.
 
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Brand NameUNKNOWN LONG GAMMA NAIL - LEFT
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 Key6244484
MDR Text Key64581285
Report Number0009610622-2017-00018
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
Type of Report Initial
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/15/2016
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: 01/11/2017 Patient Sequence Number: 1
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