MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY; TOE HEMICAP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

Arthrosurface is currently investigating the reported event.The results of the investigation will be submitted through a supplemental mdr.

Event Description

The patient received a toe df implant on (b)(6) 2017 and is not satisfied with the outcome of the case.

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.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
• Type of Device: TOE HEMICAP
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin, ma 02038
• MDR Report Key: 8945945
• MDR Text Key: 156019818
• Report Number: 3004154314-2019-00010
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K131377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other