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

Model Number	03.404.022S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hto.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during a revision procedure due to a tibial non-union on (b)(6) 2020, while applying force on the ria 2 bone harvesting kit to obtain bone graft, the pieces that attach the reamer head to the shaft splintered off inside the canal of the tibia and the reamer head came off the assembly.The pieces of metal were not able to be retrieved.Not much bone graft was acquired so a larger reamer head was used.While pulling ria2 assembly out, the reamer head got stuck and the plastic shaft snapped.The procedure was successfully completed without a surgical delay.Patient status was unknown.Concomitant device reported: unknown ria drive shaft (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 13.0mm reamer head for ria 2 sterile.This is report 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.H10: additional narrative: 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.
Event or Problem Description
The second reamer head was removed and additional bone graft was added to graft collected from the ria2.Patient was revised to a tibial nail.
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: b5 h6: the instrument(s) was not returned and instead the investigation will be done based on the received image(s).The image(s) was reviewed and the complaint condition for broken could be confirmed as the image shows fragments in the patient on the x-ray and the device picture shows metal that is sharp and looks broken.As the instrument(s) was not returned, an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
• 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: 10624712
• Report Number: 2939274-2020-04477
• Device Sequence Number: 2901363
• Product Code: HRX
• UDI-Device Identifier: 10886982274021
• UDI-Public: (01)10886982274021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

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: 03.404.022S
• Device Catalogue Number: 03.404.022S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 11/10/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 10/22/2020; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIA 2 BONE HARVESTING KIT 520MM STERILE; UNK - DRIVE SHAFT; UNK - REAMERS: REAMER HEAD; RIA 2 BONE HARVESTING KIT 520MM STERILE; UNK - DRIVE SHAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 186