PEEK CORKSCREW FT W/ NEEDLES, 4.5MM
Received Jul 17, 2008 · Event occurred Jun 1, 2008
Report 1220246-2008-00136 · MDR key 1078385
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
NACatalog number
AR-1927PNF-45
Lot number
132440
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Pus
- Surgical procedure
- Reaction
- Therapy/non-surgical treatment, additional
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONDITION REPORTED COULD BE RELATED TO AN ADVERSE PT REACTION TO ANY OF THE MATERIALS IMPLANTED. PRODUCT DFU WARNS OF A POSSIBLE ALLERGIC REACTION TO THE IMPLANT MATERIALS. PT SENSITIVITY MUST ALWAYS BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE SECOND OF TWO EVENTS REPORTED BY THE SAME SURGEON. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PT PRESENTED A REACTION POST OPERATIVELY. CULTURES PERFORMED WERE NEGATIVE. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND DRAINED THE PUS OUT. IT IS UNK EXACTLY HOW LONG POST OPERATIVELY DID THE REACTION OCCUR. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS IS THE SECOND OF TWO SIMILAR EVENTS REPORTED BY THE SAME SURGEON AND MEDICAL FACILITY. THIS DEVICE IS USED FOR TREATMENT.