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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL LONG, LEFT T2 PROX. HUM. Ø8X220 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL LONG, LEFT T2 PROX. HUM. Ø8X220 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18322822S
Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/22/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The (b)(6) reported us by fax the following event; during a surgery, doctor noticed that the humeral nail was not cannulated. The nail was implanted with difficulty. It was impossible for the surgeon to comply with the surgical protocol. Surgical delay was about 1 hour and the patient's humerus was fractured.
 
Manufacturer Narrative
Evaluation revealed the proximal humeral nail long to be the primary product. Further product details were not reported. The initially reported event of allegedly missing cannulation was not confirmed as the presence of the cannulation was confirmed by the complainant. Furthermore the dhr confirmed that the cannulation had been checked 100% during manufacturing. No deviations were found during review of the manufacturing and inspection documents (dhr); the proximal inner threads of all nails were 100% inspected regarding their function. The nail in question was documented as faultless prior to distribution. Since the nail was not returned for evaluation (still implanted) visual, dimensional as well as material investigation could not be performed. The reported problems of correct positioning of the nail on the guide (target device) could not be evaluated due to missing device and further investigation. A potential reason can be oblique or incomplete assembly of nail and nail holding screw on the target device. The operative technique includes that the fitting and setting of the nhs shall be ensured in every case prior to the nail insertion. Evaluation does not reveal a deficiency regarding design, material, manufacturing or dimensions. Based on the available information a more precise statement is not possible.
 
Event Description
The ansm reported us by fax the following event; during a surgery, doctor noticed that the humeral nail was not cannulated. The nail was implanted with difficulty. It was impossible for the surgeon to comply with the surgical protocol. Surgical delay was about 1 hour and the patient's humerus was fractured.
 
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Brand NamePROXIMAL HUMERAL NAIL LONG, LEFT T2 PROX. HUM. Ø8X220 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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5853112
MDR Text Key51355856
Report Number0009610622-2016-00391
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K043404
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 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18322822S
Device Lot NumberKOCD149
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/08/2016 Patient Sequence Number: 1
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