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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18964035S
Device Problem Incorrect Measurement (1383)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/07/2013
Event Type  Injury  
Manufacturer Narrative
The evaluation revealed the t2 locking screw, 35 mm to be the subject product. No deviations were found during review of the manufacturing and inspection documents (dhr). The screw was documented as faultless prior to distribution. Review of complaint history, capa databases, risk analysis and labelling did not identify any discrepancies. There were no open actions in place related to the reported event for the subject product(s). No non-conformity was identified. From technical point of view a physical investigation was not possible because the item was not available. According to received information the implant(s) had not been at fault at any stage. Referring to received x-rays a product deficiency was not determined (all undamaged in place after approx. 16 months) ¿ nor was any product deficiency complained in any of the received documents. It could not be determined why the distal of the proximal locking screws had been placed aside the nail whereas the proximal screw had been placed correctly in the nail¿s drill hole. With given information a further technical statement was not possible. A medical review revealed no causal correlation determined regarding potential dysfunction of stryker manufactured implants and the listed impairments. With available information a deficiency of the device was not verified. Device was not received.
 
Event Description
The origin of the event is caused by a legal action against a surgeon as an alleged result by a bad practice. It has been legally reported by the patient that a potential bad practice in the implantation of the product involved (brand t2 humerus) happened. Stating that the length of the screw was bigger than he wondered. It has been reported by the patient that according to him he suffered pain and lack of mobility.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The origin of the event is caused by a legal action against a surgeon as an alleged result by a bad practice. It has been legally reported by the patient that a potential bad practice in the implantation of the product involved (brand t2 humerus) happened. Stating that the length of the screw was bigger than he wondered. It has been reported by the patient that according to him he suffered pain and lack of mobility.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X35 MM
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 Key6490909
MDR Text Key246952530
Report Number0009610622-2017-00113
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K003018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Catalogue Number18964035S
Device Lot NumberK648152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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: 04/13/2017 Patient Sequence Number: 1
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