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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250360S
Device Problem Fracture (1260)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Ambulation Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reports the following: material breakage without external influence. The patient is announced to us by the neustadt clinic with another periprosthetic femur fracture on the left side. The patient had fallen on the stairs while cleaning at home on (b)(6) 2020 and suffered a subtrochanteric femur fracture on the left side. She was treated as described above on (b)(6) 2020 at the (b)(6) clinic. The intra- and postoperative course was unremarkable. The patient underwent a rehabilitation measure, which also did not show any abnormalities. During the last weeks, increasing complaints on the left side with groin pain developed. For a few days now, the symptoms have been increasing significantly. The patient did not fall again. She has already had problems walking for several weeks, and stress-related pain. In further diagnostics, the peri-implant fracture with of the implanted gamma nail on the left side is shown and the patient is transferred to our clinic. Removal of material and reosteosynthesis using pfn 340/12 in domo.
 
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Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 125
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10483587
MDR Text Key205472157
Report Number0009610622-2020-00495
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33250360S
Device Lot NumberK0C6581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2017
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: 09/02/2020 Patient Sequence Number: 1
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