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

Model Number SEEG DRILL ADAPTOR 3.20MM

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a surgery, while the surgeon was drilling through the 3.20mm drill adaptor s/n (b)(4), the 3.2 smith and nephew drill bit fused within it.The jam could not be resolved, so a new drill bit and drill adaptor had to be used.It was reported that the drill adaptor was irreparably damaged and the drill bit could not be removed, so it was disposed of in the hospital¿s sharps bin.No picture was made available for investigation.Such drill adaptor issues were analyzed by a hardware engineer as part of capa.This evaluation determined that the drill adaptor design has to be improved.Unique identifier (udi) #: unknown.

Event Description

Company representative (cr) was present for an rns case.During the case, cr drove to the 1st (left) trajectory for drilling.Once at that trajectory, the surgeon started drilling.Partway through the bone, the drill bit and drill guide fused together and could not be separated.The drill bit was a 3.2 smith and nephew bit, and no irrigation or mineral oil was used for drilling.A new drill bit and drill guide had to be opened to finish the case.The drill guide was irreparably damaged and the drill bit could not be removed, so it was disposed of in the hospital¿s sharps bin.No impact to patient, after first incision and patient was under anesthesia.Delay to case less than 10 mins.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, 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: 11900240
• MDR Text Key: 253128669
• Report Number: 3009185973-2021-00143
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEEG DRILL ADAPTOR 3.20MM
• Device Catalogue Number: ROSAS00084
• Device Lot Number: MPL174045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1