HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
Received Aug 29, 2019 · Event occurred Oct 27, 2017
Report 3004154314-2019-00010 · MDR key 8945945
Device
Generic name
Toe Hemicap
Manufacturer
Arthrosurface, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Complaint, Ill-Defined
- Complaint, Ill-Defined
Narrative
Additional Manufacturer Narrative
THE PATIENT WENT IN FOR A TOE HEMIARTHROPLASTY SURGERY ON (B)(6) 2017. THE SURGEON INITIATED THE SURGERY AND REALIZED THAT A HEXDRIVER HE WANTS TO USE WAS MISSING FROM THE INSTRUMENT KIT. THE SURGEON RESCHEDULED THE CASE AND COMPLETED IT THE FOLLOWING DAY. THE PATIENT BELIEVES THAT THE DELAY IN SURGERY AND MISSING INSTRUMENTATION ARE CONTRIBUTING TO THE PAIN AND SWELLING. ACCORDING TO THE DISTRIBUTOR, MISSING HEX DRIVER WAS POSSIBLY A RESULT OF MIX-UP AT THE HOSPITAL FROM THE PREVIOUS CASE THAT WENT UN-NOTICED. ARTHROSURFACE HAS APPROPRIATE PROVISIONS AND CONTROLS IN PLACE FOR USING THE INSTRUMENTS AND RETAINING THEM IN THE KITS FOLLOWING THEIR USE. SINCE THE INCIDENT OCCURED BEYOND ARTHROSURFACE CONTROL AND A SETTLEMENT WAS REACHED BETWEEN THE PATIENT AND THE HOSPITAL, THE COMPLAINT WILL BE CLOSED AT THIS TIME.
Additional Manufacturer Narrative
ARTHROSURFACE IS CURRENTLY INVESTIGATING THE REPORTED EVENT. THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED THROUGH A SUPPLEMENTAL MDR.
Description of Event or Problem
THE PATIENT RECEIVED A TOE DF IMPLANT ON (B)(6) 2017 AND IS NOT SATISFIED WITH THE OUTCOME OF THE CASE.