MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE

Model Number	03.404.020S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) 2020 during a bilateral femur case the reamer head for the reamer irrigator aspirator (ria 2) broke while reaming.The reamer prongs broke while reaming the second leg.There were retained fragments in the lesser troch area.The broken reamer was pulled out using the ball tip guide wire.The procedure was successfully completed with a minimal surgical delay.Patient status is unknown.This report is for one (1) 12.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.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.
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, h4, h6: part: 03.404.020s, lot: 51p3938: release to warehouse date: march 30, 2020.Expiration date: february 28, 2030.Supplier: jabil-monument.No no-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: the reamer heads proximal prongs were completely broken off, they were not returned.There was a red substance that was located on the reaming head.The substance was probably blood residue that was not removed during sterilization.Since no x-rays were provided capturing the embedded prongs, the reported condition of an embedded device was not confirmed however the overall complaint was confirmed due to the broken prongs.The dimensional inspection was not performed due to post manufacturing damage.The current and manufactured to drawings were reviewed.The overall complaint was confirmed.Although no definitive root-cause can be determined the reamer head may have been subjected to unexpected forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document / specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 12.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11055508
• Report Number: 2939274-2020-05675
• Device Sequence Number: 3311438
• Product Code: HRX
• UDI-Device Identifier: 10886982273987
• UDI-Public: 10886982273987
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.020S
• Device Catalogue Number: 03.404.020S
• Device Lot Number: 51P3938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 10/15/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/14/2021; 10/15/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0575-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR