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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® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250340S
Device Problems Break (1069); Fracture (1260)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that patient stumbled on (b)(6) 2018 behind her walker and fell on her couch. She had sustained a "sub pertrochanteric fracture". An elongated gamma3 nail was placed in an (b)(6) female patient at (b)(6) 2018, position: left proximal femur. Post surgical protocol: mobilization in reliance on pain: patient used a walker for movement. After the initial surgery the patient could start carefully load her injured leg again following normal protocol. Patient didn¿t fall nor jump nor did anything else that compromised her health and recovery. In the first week of (b)(6) she developed pain in her left hip which persisted already a few days. On the (b)(6) an x-ray was taken. The nail seemed to be broken. That day or nurse, got in touch to investigate what instruments where available for extracting the broken nail and the revision or was planned on the (b)(6).
 
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Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM 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
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 Key8597225
MDR Text Key144668371
Report Number0009610622-2019-00243
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 Physician Assistant
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33250340S
Device Lot NumberK05E004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2018
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: 05/09/2019 Patient Sequence Number: 1
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