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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 PROXIMAL HUMERAL NAIL -LONG NAIL- 260 MM IMPLANT

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STRYKER TRAUMA KIEL T2 PROXIMAL HUMERAL NAIL -LONG NAIL- 260 MM IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Neuropathy (1983); No Code Available (3191); Paresthesia (4421)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
The reported event that t2 proximal humeral nail - short nail- 260 mm was alleged of issue adverse impact on patient / patient related / iatrogenic issue, could not be confirmed since the device was not returned for evaluation and no other evidences were provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose. A review of the labeling did not indicate any abnormalities. If any further information is provided, the investigation report will be updated. Device disposition unknown.
 
Event Description
The manufacturer became aware of a 'retrospective data collection report' from (b)(6). The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn). Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017. It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication. Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses polyneuropathy, paraesthesia. The report states, "polyneuropathy with paraesthesia at hands and feet was reported by a (b)(6) caucasian male with diaphyseal humeral fracture treated with t2 phn. The patient therefore wished the removal of the implant. The nail was removed 16 months after the fracture. The fracture was consolidated (#84). ".
 
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Brand NameT2 PROXIMAL HUMERAL NAIL -LONG NAIL- 260 MM
Type of DeviceIMPLANT
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8244376
MDR Text Key132959673
Report Number0009610622-2019-00043
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/14/2019 Patient Sequence Number: 1
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