MAUDE Adverse Event Report: SYNTHES USA; REAMER

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A product investigation was completed: the complaint condition for the 352.085 lot number 18079 8.5 medullary reamer head and the unknown reaming rod was likely caused by over seven years of use; however, this complaint is not likely a result of any design related deficiency.Per the technique guide, the 352.085 8.5mm medullary reamer head and the reaming rod are instruments routinely used in the flexible reamers for intramedullary nails system.The devices were returned and reported to have broken while reaming a femur for a trochanteric fixation nail.This condition is confirmed; the distal circumference of the reamer head is entirely broken off along a jagged fracture surface.The small ball from the distal tip of the reaming rod was returned broken from the shaft of the device.It is likely that seven years of use had dulled the reamer head causing it to break during use leading to this complaint condition.The reaming rod likely broke at the same time the reamer head broke apart.The 352.085 reamer head was manufactured in june 2008 and is over seven years old.The balance of the returned device is in fairly worn condition with some markings along the cutting edges.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Without a lot number the device history records review could not be completed.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 during the insertion of a trochanteric fixation nail (tfn), an 8.5 mm reaming head broke inside the patient during reaming.Some pieces of the reamer head remained retained in the patient.There was a ten to fifteen (10 to 15) minute surgical delay reported.Procedure was completed successfully.The small ball from the distal tip of the reaming rod was returned broken from the shaft of the device.The device was found upon investigation by the manufacturer.(b)(4).

Manufacturer Narrative

Report was initially submitted on (b)(6) 2015, but the fda site was down.Advised by fda on (b)(4) 2015 to resubmit medwatch.Device 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.

• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5152979
• MDR Text Key: 28368278
• Report Number: 2520274-2015-16685
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 61 YR