MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number 03.404.022S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that on an unknown date, the patient underwent for a surgery.During the surgery, the superior tabs for the reaming head for reamer irrigator aspirator (ria) 2 broke off inside the driveshaft.The head became disconnected from the shaft while reaming.There was no surgical delay.The procedure outcome was unknown.There was no patient consequence reported.Concomitant device reported: unknown drive shaft (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 13.0mm reamer head for ria 2 sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Additional product code: hrx.The device was received, the investigation is in progress, 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.

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.This complaint is confirmed, as all four holding prongs had broken off.Which caused the complaint condition.Due to the trend with the broken ria 2 reamer heads identified, during post market surveillance.The capa was raised to determine, the root cause of broken head breakages.Additionally, the product issue escalation (pie (b)(4)) was initiated to define any further action related to the breakage.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined, that no corrective and/or preventive action is proposed.Device history lot: manufacturing location: supplier ¿ (b)(4), release to warehouse date: 11-aug-2020, expiration date: 30-jun-2030, part number: 03.404.022s, 13.0mm reamer head for ria 2-sterile, lot number: 64p7069 (sterile), component part(s) reviewed: part number: 03.404.M022, ria 2 reamer head 15.0mm, lot number: 7009006.Device history review: this lot met all dimensional, visual, sterility and packaging criteria with no issues documented, during the inspection or release of the product that would contribute to this complaint condition.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: 13.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12901825
• MDR Text Key: 286923515
• Report Number: 2939274-2021-06864
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982274021
• UDI-Public: (01)10886982274021
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.022S
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 64P7069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0577-2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS