MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number	03.404.024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: additional product code: hto.Reporter is a j&j sales representative.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.
Event or Problem Description
It was reported that on (b)(6) 2021 the patient underwent for a surgery.During the surgery, the reamer irrigator aspirator (ria) 2 reamer shaft and reamer head connection tabs broke during reaming and also could not remove ria 2 flex reamer shaft from the disposable ria 2 shaft.The surgery was delayed for 7-10 minutes.Fragments removed.Used other shaft to complete reaming.The procedure was successfully completed.This complaint involves two (2) devices.This report is for (1)14.0mm reamer head for ria 2 sterile this report is 2 of 2 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.H3, h6: a product investigation was conducted.Visual inspection: the 14.0mm reamer head for ria 2 sterile (p/n: 03.404.024s, lot #: 6823004) was returned and received at us cq.Upon visual inspection, it was observed that the reamer head prongs were broken and the broken fragments were returned.No other issues were identified.Dimensional inspection: complaint relevant dimensional inspection cannot be performed due to the post manufacturing damage / device geometry.Document/specification review: the relevant documents were reviewed: no design issues or discrepancies were identified.Investigation conclusion: the complaint condition was confirmed as the device was broken.Due to the trend with the broken ria 2 reamer heads identified during post market surveillance, the corrective and preventative action (capa) was raised to determine the root cause of broken head breakages.Additionally, the product issue escalation (pie) was initiated to define any further action related to the breakage.No new malfunctions were observed during this investigation that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: supplier ¿ (b)(4)/ inspected and released by: monument, release to warehouse date: 18-dec-2019, part number: 03.404.M024, lot number: 6823004 , lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Certification for heat treat supplied was reviewed and determined to be conforming.Raw material certificate of compliance was reviewed and determined to be conforming.Raw material certificate of tests was reviewed and determined to be conforming.This lot met all dimensional and visual criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.H9: 3008812560-10/26/2020-001-c.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: 14.0MM 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: 11904571
• Report Number: 2939274-2021-02673
• Device Sequence Number: 3551001
• Product Code: HRX
• UDI-Device Identifier: 10886982274069
• UDI-Public: 10886982274069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/03/2021

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: 03.404.024S
• Device Catalogue Number: 03.404.024S
• Device Lot Number: 6823004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT FOR RIA 2 520MM
• Patient Age: 42 YR