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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN JIG T2 TIBIAL NAIL KIT INSTRUMENT

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STRYKER TRAUMA KIEL UNKNOWN JIG T2 TIBIAL NAIL KIT INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pressure Sores (2326); Tissue Breakdown (2681)
Event Date 08/29/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The customer reported that the patient underwent a t2 tibial nail procedure. After the procedure when the patient was leaving theatre staff noticed a pressure sore on the skin above the incision point. The pressure sore was described as red, approximately 2 cm in diameter with broken skin in the middle of the sore / red area. The patient required a dressing for the sore. The scrub team thought that the use of the jig may have contributed to the pressure sore. This was the first time the surgeon had used the jig. The stryker sales representative was in the case and commented that in general the jig is used with the leg in the bent position and that in this case at one point, whilst the jig was in use, the scrub nurse flattened the leg to implant an end cap.
 
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Brand NameUNKNOWN JIG T2 TIBIAL NAIL KIT
Type of DeviceINSTRUMENT
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 Key5976324
MDR Text Key55567534
Report Number0009610622-2016-00449
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/26/2016 Patient Sequence Number: 1
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