MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE

Model Number 03.404.018S

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 drive shaft.It was unknown if there was a surgical delay.The procedure outcome was unknown.There was no patient consequence.Concomitant device reported: unknown drive shaft (part# unknown, lot# unknown, quantity 1).This report is for one (1) 11.0mm reamer head for ria 2 sterile.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: 11.0MM 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
• MDR Report Key: 10863759
• MDR Text Key: 217451523
• Report Number: 2939274-2020-05214
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273963
• UDI-Public: 10886982273963
• 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
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1
• Patient Age: 29 YR