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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. HUNTER SPATULA, ORTHOPEDIC

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WRIGHT MEDICAL TECHNOLOGY, INC. HUNTER SPATULA, ORTHOPEDIC Back to Search Results
Model Number TR300000
Device Problem Material Rupture (1546)
Patient Problems Failure to Anastomose (1028); No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2017
Event Type  Injury  
Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

 
Event Description

It was reported that the patient underwent a surgical procedure. Sometime post-op the tendon rod ruptured. The patient underwent a revision surgery to remove and replace the tendon rod. No additional patient complications were reported.

 
Manufacturer Narrative

The tendon rod was returned for evaluation. Visual examination confirms that the device has fractured at the sutured end of the rod. Also visual examination shows that the suture had not been passed through the polyester core which indicates that the suture was not passed through the polyester tape core initially.

 
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Brand NameHUNTER
Type of DeviceSPATULA, ORTHOPEDIC
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer Contact
dustin smith
1023 cherry road
901451-631
MDR Report Key6710086
MDR Text Key79909500
Report Number1043534-2017-00076
Device Sequence Number1
Product Code HXR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK853438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberTR300000
Device LOT Number1594606
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/15/2017
Event Location Home
Date Manufacturer Received06/15/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2017
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: 07/13/2017 Patient Sequence Number: 1
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