MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIA 2 BONE HARVESTING KIT 520MM STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number 03.404.000S

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code : hto.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, patient underwent a surgical procedure for unknown reason.The reamer irrigator aspirator (ria 2 )sterile tube assembly broke during surgery.No adverse events to the patient.Opened up second shaft and completed procedure.There was no surgical delay.Patient outcome after the procedure is unknown.This complaint involves two (2) devices.This report is for (1) ria 2 bone harvesting kit 520mm sterile.This report is 2 of 2 (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.Further information provided indicated only one reamer irrigator aspirator (ria 2) sterile tube assembly broke.This event is fully captured on manufacturer repot number 2939274-2021-02098.

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11733711
• MDR Text Key: 248216460
• Report Number: 2939274-2021-02099
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982274236
• UDI-Public: 10886982274236
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 03.404.000S
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 92P7397
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RIA 2 BONE HARVESTING KIT 520MM STERILE.