MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE

Model Number 03.404.016S

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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) 2020 the three (3) reamer heads for reamer irrigator aspirator ria 2 broke off during reaming, which caused the heads to disengage from the driveshaft. It was unknown if there was a surgical delay. The procedure outcome was unknown. There was no patient consequence. Concomitant device reported: unknown driveshaft (part# unknown, lot# unknown, quantity 1). This report is for one (1) 11. 0mm reamer head for ria 2 sterile. This is report 2 of 3 for (b)(4).

• Brand Name: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10863880
• MDR Text Key: 217453298
• Report Number: 2939274-2020-05215
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273932
• UDI-Public: 10886982273932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown