MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number MAYFIELD HEAD HOLDER ADAPTOR

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The mayfield head holder adapter from device br16025 has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that after being used for the last surgery the mayfield head holder adaptor was in perfect condition, and after was found damaged within the storage area.Site claims they do not know what happened, but suspect that it was damaged in the storage area or in the hallway during transit.

Manufacturer Narrative

It was reported that the pin of a mayfield head holder adaptor was found bent.According to visual inspection, the damage could not have been caused by tightening of the part with excessive force.According to the medtech representative, the part was correct during the previous surgery.According to the hospital, the part could have been damaged during storage or transit.The most probable root cause is that the part was dropped down during storage or transit within the hospital.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; languedoc-roussillon 34000 ; FR 34000
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7056985
• MDR Text Key: 93477952
• Report Number: 3009185973-2017-00806
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAYFIELD HEAD HOLDER ADAPTOR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1