HUNTER TENDON ROD
Received Jun 14, 2013 · Event occurred May 3, 2013
Report 1043534-2013-01044 · MDR key 3170391
Device
Generic name
Small Joint Component, Code:hxa
Manufacturer
Wright Medical Technology, Inc.Catalog number
TR30-0000
Lot number
1458122
Product problems
- Insufficient Device Problem Information
Patient
24 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES WERE MADE OF RETURNED PRODUCT. (B)(4).
Additional Manufacturer Narrative
THIS INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
ALLEGEDLY POST-OP CONSULTATION ON (B)(4) 2013 - NO OPEN SPOTS. BUT ON (B)(4) 2013, PT. DEVELOPED OPEN WOUND SPOTS ON PROXIMAL AND DISTAL PORTIONS OF FINGER. ON (B)(6) 2013 PT HAD DEVELOPED LOW GRADE SEPSIS. DR REMOVED ROD.