MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - REAMERS: REAMER HEAD

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - reamers: reamer head/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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 Description

It was reported that on (b)(6) 2020, while the surgeon was using the reamer irrigator aspirator (ria) system for bone graft harvest from the right femur to repair a tibial non-union the tip of the ria drive shaft was broken, and the tip remained lodged in the ria reamer head.The surgeon measured the medullary canal during pre-operative scout x-rays and a 16.5mm ria reamer head was chosen for the ria assembly based on a 16mm canal measurement.Ria was tested for proper connections and irrigation/aspiration before inserting it in the patient.He encountered difficulty before the reamer reached the isthmus and decided to change the ria head to 16mm.Upon 2nd pass, the reamer was unable to advance passed the isthmus again.After troubleshooting, it was found out that the aspiration was clogged and there wasn't any bone graft collected in the ria filter.At that point, everything was disassembled and was discovered that the tip of the ria drive shaft was broken.Ria shaft was changed and jumped up to a 17.0mm ria reamer head since it was the only size left to choose from.No broken pieces remained in the patient.There was a 30 minutes surgical delay.The procedure was successfully completed.There was no patient consequence.This is report 02 of 04 of (b)(4).

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: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - REAMERS: REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9699640
• MDR Text Key: 190346840
• Report Number: 2939274-2020-00787
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 107