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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 Fracture (1260); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  Injury  
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. Device disposition is unknown.
 
Event Description
It was reported by the customer service (b)(4), that mr. (b)(6) called about a surgery regarding his sister in law (approx. (b)(6) years old) has undergone at the (b)(6) in (b)(6) 2017 involving the stryker gamma nail. In (b)(6) 2017, she had to undergo surgery again as there was a fracture (unclear if it was a fracture of the gamma nail or the bone). In 2018 she had another surgery (separate (b)(4)). It was indicated that the initial call was to ask what the warranty is for a gamma nail. He was told that he needs to contact the hospital and that the hospital then can contact stryker if there would be an issue with one of our products. He understood that they are in discussion with the hospital as they think it is a medical error. The legal advisor of the hospital they have contact with is mr. (b)(4).
 
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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
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 Key7607220
MDR Text Key111296635
Report Number0009610622-2018-00243
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
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: 06/15/2018 Patient Sequence Number: 1
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