MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that on (b)(6) 2019, a medullary reamer head was disengaged from the reamer shaft during a total hip procedure.The surgeon did not place the flexible reamer shaft with reamer head over a reaming rod and the reamer head that was used disengaged from the flexible reamer shaft and was lodged in the femoral canal.They were unable to retrieve the reamer head.Procedure was successfully completed, total hip procedure performed as planned.It was relayed that the patient is recovering fine from the total hip procedure and not given amount of time delayed.There was an attempt to retrieve the reamer head, but that specific information was not supplied, nor was other intervention information.The reason for the total hip procedure was not supplied to sales consultant but mostly performed for osteoarthritis.Sc confirmed this was not a fracture related procedure.Concomitant device reported: unknown flexible reamer shaft (part# unknown, lot# unknown, quantity# 1).This report is for one (1) synream flexshaft.This is report 2 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 corrected data: d4: udi number.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.

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.No concomitant devices.Previous reported concomitant device became an impacted product.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

Update: no concomitant devices.Previous reported concomitant device became an impacted product.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 80132
• MDR Report Key: 8842023
• MDR Text Key: 152675315
• Report Number: 1719045-2019-50006
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243668
• UDI-Public: (01)07611819243668
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR