MAUDE Adverse Event Report: SYNTHES USA 14.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.255S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

Exact age is unknown; reported as (b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) additional x-rays.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 intramedullary (im) of the knee procedure was performed on (b)(6) 2016 and during bone grafting of the femur the reamer head separated from the drive shaft.The surgeon realized this malfunction after completion of the reaming process, when he pulled the drive assembly out.It was noticed through additional x-rays that, the head was separated and was retrieved from patient within thirty (30) seconds.In addition, the tip of the drive shaft broke inside of the head.Procedure was completed successfully with five (5) minutes surgical delay, all broken fragments were retrieved and patient status was reported as non-eventful.Concomitant devices: reamer, irrigator, aspirator (ria) tube (part 314.746s, lot unknown, quantity 1); locking clip (part unknown, lot unknown, quantity 1); drive shaft seal (part 351.718s, lot unknown, quantity 1).This is report 1 of 2 for (b)(4).

• Brand Name: 14.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5984079
• MDR Text Key: 55871871
• Report Number: 2520274-2016-14729
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.255S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT SEAL (351.718S); REAMER, IRRIGATOR, ASPIRATOR (RIA) TUBE (314.746S); UNKNOWN LOCKING CLIP
• Patient Outcome(s): Required Intervention