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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34301360S
Device Problem Fracture (1260)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Concerns (b)(6), cognitive good. Vg / osteoporosis after chronic prednisone use and 10j bisphosphonates. On (b)(6) 2018 operation 1, other operator, comminuted subtrochanteric femoral shaft fracture with large shard medial open reposition and cerclages, placement of long gamma nail 125gr followed by twining of cerclages. No specific problems mentioned. By appointment operator 100% loaded mobilization from intervention, initially no problems with loading. Uncomplicated course, wound healing. On (b)(6) 2019: without trauma suddenly to burden pain and inability, broken gamma nail on collum hole and redislocation, no signs infection. On (b)(6) 2019: operation 2: removing the pen and screws, no specific features, possible sharpened collum-hole pin bot revives, places dbx (gf) and spongiosa, places new extended gamma nail 130gr, uncomplicated. Peroperative cultures negative. This is reported in per (b)(4). On (b)(6) 2019: gamma nail broken again.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 130°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key8732801
MDR Text Key149176853
Report Number0009610622-2019-00521
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K034002
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 08/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number34301360S
Device Lot NumberK067263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/26/2018
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: 06/25/2019 Patient Sequence Number: 1
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