MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA PERINEAL POST; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 6850-413

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Patient had nerve damage after hip arthoscopy.

Manufacturer Narrative

The surgeon user, is unclear on what perineal posts he has used with the hana table.According to the facility previously used the smith & nephew perineal post, although it is unclear if was used with the hana table off-label.Since the inception of their use of mizuho osi 6" diameter perineal post, the surgeon has seen an increase in incidence of temporary nerve palsy.Doctor claims that previously he also had an incidence of temporary nerve palsy.The size of his patients has not changed, and his surgical case length is consistent with the past.He has begun to wrap the posy with webril following the patient incident.Doctor has made this change on his own accord.Mizuho osi clinical marketing specialist me with the facility's staff to review and confirm their awareness of the risk associated with this procedure ((b)(6) 2016).Device not returned.

Event Description

Patient had nerve damage after hip arthoscopy.

• Brand Name: HANA PERINEAL POST
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 5644901
• MDR Text Key: 44886292
• Report Number: 2921578-2016-00009
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 6850-413
• Device Catalogue Number: 6850-413
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other