MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number	03.404.026S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer 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) 2020, the splines of a 15mm reamer irrigator aspirator (ria) 2 head sheared off in a patient femoral canal while using ria 2 for bone harvesting.Fragments were generated from a broken device, but the small pieces were left in the femoral canal as the intramedullary nail was placed.There was no surgical delay reported.The procedure was successfully completed.Patient status was unknown.Concomitant devices reported: unknown ria (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device has been 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.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.H10 additional narrative: h3, h4, h6 investigation summary: visual inspection: the 15.0mm reamer head for ria 2 sterile( p/n: 03.404.026; lot # unk) was received at us cq.Upon visual inspection it was noticed that the proximal end of the reamer where it is inserted into the drive shaft has completely broken off and the broken pieces were not returned.The reported condition of embedded device was not confirmed as there is no evidence of images/x-rays are provided.No other issues were identified with the device.Device failure/ defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: 14.0mm reamer head ria2.Complaint confirmed? yes; received device was broken.Conclusion: the complaint condition is confirmed for the 15.0mm reamer head for ria 2 sterile( p/n: 03.404.026; lot # unk).A manufacturing record evaluation could not be performed as the lot number could not be determined on the received device.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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: 15.0MM 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: 10112645
• Report Number: 2939274-2020-02644
• Device Sequence Number: 3407940
• Product Code: HRX
• UDI-Device Identifier: 10886982273956
• UDI-Public: (01)10886982273956
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K993335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2020

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: 03.404.026S
• Device Catalogue Number: 03.404.026S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 06/30/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/12/2020; 07/02/2020
• 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: UNK - RIA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR