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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNK DISTAL SCREW IMPLANT

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STRYKER TRAUMA KIEL UNK DISTAL SCREW IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Irritation (1941)
Event Date 11/01/2012
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device not available to stryker.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6). The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of tibial fractures with the t2 tibial nailing system¿ which was published in june 2018 and is associated with the t2 tibial nailing system. Within that publication, postoperative complications/ adverse events were reported, which occurred between november 2012 to september 2017. It was not possible to ascertain specific device or patient information from the article, 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 66 complaints were initiated retrospectively for different adverse events mentioned in the journal. This product inquiry addresses hardware irritation. 2 out of 6 cases. The pmcfr states: ¿subject a. 2 was a (b)(6) year old caucasian male, with a left open tibia fracture (gustillo iiib) after a motor vehicle accident. Concurrent multi-trauma and organ injury was present on admission; orthopaedic injuries also present on admission included right hip acetabular fracture and femoral head fracture, left open distal femur fracture. Subject has a history significant for previous tobacco use. Subject underwent serial irrigation and debridements, initial external fixation placement, antibiotic bead placement and removal, and final definitive fixation (34 days from the external fixation placement). A t2 tibia nail was placed in the transverse only mode (medial to lateral) with 3 distal screws across 2 planes. Subject spent 42 days in the hospital from the time of initial injury and was discharged on post-op day (pod) #8 after the definitive surgery to an acute rehabilitation center, non-weightbearing. Subject during the follow-up period, chronologically experienced wound healing disturbances on 2 occasions, nonunion, and then hardware irritation. Hardware irritation occurred 251 days after definitive surgery. At his 6 month follow-up visit, subject complained of medial skin breakdown over the medial aspect of the left ankle near the distal interlocking screw. Subject returned for surgery with an irrigation and debridement with removal of hardware. ¿.
 
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Brand NameUNK DISTAL SCREW
Type of DeviceIMPLANT
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
melissa guattery
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7682861
MDR Text Key113869290
Report Number0009610622-2018-00304
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
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 Received06/25/2018
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: 07/12/2018 Patient Sequence Number: 1
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