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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LONG NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LONG NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Failure To Adhere Or Bond (1031); Break (1069)
Patient Problem No Code Available (3191)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device not available.
 
Event Description
The customer reported an extraction hook was broken. The instrument has been raised under pi (b)(4). The report stated that it broke during a revision case. This pi is open to reflect that revision. The surgery was to remove a broken right side gamma3 long nail which was implanted approximately 2yrs ago at the (b)(6) by another surgeon, and replaced with an omega dhs. The nail had broken at the point where the lag screw crosses through and there was mal-union of the initial fracture site. The lag screw, 5mm distal locking screw and proximal part of the nail were extracted. The distal portion of the nail remains in situ.
 
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Brand NameUNKNOWN GAMMA3 LONG NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7301191
MDR Text Key101118202
Report Number0009610622-2018-00057
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
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
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 Received02/22/2018
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: 02/27/2018 Patient Sequence Number: 1
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