MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.5MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number	03.404.019S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: additional product code: hto.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 or Problem Description
It was reported that on (b)(6) 2021, patient underwent an unknown surgical procedure for unknown reason.While reaming the femur with a 10.5mm reamer irrigator aspirator (ria) 2 head, the head broke off and left the four tabs in the femur.Then opened a 11.5 head, and it broke the second or third in and out motion.The surgeon then passed regular reamer to size 11mm and completed the case with an additional 11.5mm ria 2 head.Case delayed by 40 minutes.The surgeon retrieve the 8 metal tabs that were left from broken heads.The procedure was completed successfully with a surgical delay of 40 minutes.There was no patient consequence.This complaint involves three (3) devices.This report is for (1)11.5mm reamer head for ria 2 sterile this report is 3 of 3 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 11.5MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12069615
• Report Number: 2939274-2021-03245
• Device Sequence Number: 4110545
• Product Code: HRX
• UDI-Device Identifier: 10886982273970
• UDI-Public: (01)10886982273970
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.019S
• Device Catalogue Number: 03.404.019S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 10/18/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0574-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5MM REAMER HEAD FOR RIA 2 STERILE; DRIVE SHAFT FOR RIA 2 520MM
• Patient Age: 17 YR