MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.742

Device Problem Fitting Problem (2183)

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

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records was conducted.The report indicates that themanufacturing location: dhr review part number: 314.742 synthes lot number: 7081941 release to warehouse date: 22-jul-2013 supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 a reamer head broke during reaming of the left tibia canal for insertion of an antibiotic nail.The reamer shaft is stuck in the reamer irrigator aspirator (ria) assembly tube.No fragments remained in the patient.There was no delay in surgery.The procedure was successfully completed with a successful patient outcome.This complaint involves three devices.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product investigation was completed: the complaint condition was able to be confirmed at customer quality as the reamer head was returned broken at the base of the four (4) fingers.The broken portions were not received.Replication of the complaint is not applicable as the device was returned broken.One drive shaft and one ria tube assembly were received stuck together.The items were sent through decontamination, but were unable to be completely cleaned as they could not be disassembled.The tube assembly still contains a small amount of blood.The tip of the drive shaft (within the tube) shows some evidence of damage, which may have come from the broken reamer head.This may explain why the items cannot be separated.The end of the drive shaft does not show any signs of damage outside of normal wear and tear.The ria tube assembly has some unknown debris on the inside of it.The exterior does not show any signs of damage outside of normal wear and tear.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.Per the technique guide a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900rpm is to be used.The technique guide also cautions that no reduction drive units or drills with a torque greater than 6nm should be used.During use, the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.Product drawings for the reamer head, drive shaft, and tube assembly were reviewed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The complaint condition is the result of an overload of forces to the distal end of the drive shaft resulting in stresses beyond the failure limit.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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: DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5665593
• MDR Text Key: 45471968
• Report Number: 1719045-2016-10416
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.742
• Device Lot Number: 7081941
• Other Device ID Number: (01)10886982189035(10)7081941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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: 18 YR
• Patient Weight: 129