MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: dhr review, part number: (b)(4), synthes lot number: 7312609, release to warehouse date: (b)(6) 2013 supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this 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

Device report from synthes on an event in (b)(6) as follows: it was reported that during the inspection of the returned device, the (b)(6) technician noted that the distal end of the ria drive shaft was broken.No information available when and where the device broke.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).A product development investigation was performed for the subject device (drive shaft-minimum 520mm length-for use with ria, part number 314.743, lot number 7312609).The subject device was returned to synthes customer quality with the complaint stating that the distal end was broken.Further evaluation at customer quality shows that, 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 per the reamer/irrigator/aspirator (ria) technique guide.The drive shaft was received with the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The balance of the device shows surface wear but is in functional condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.A review of the current design drawing / manufactured revision for the top level assembly and the drive shaft component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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 of the shaft.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.The reamer/irrigator/aspirator (ria) technique guide addresses recommended use.Step 5 under ¿assembly,¿ states that 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.Step 2 under ¿reaming¿ describes the recommend use for reaming as follows; ¿begin reaming, using a gradual advance/retract technique.Slowly advance 20-30mm and then retract 50-80mm allowing the irrigation fluid to flow in front of the reamer head.Advance the assembly until resistance is felt, then repeat.¿ (b)(4).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 520MM 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: 5648602
• MDR Text Key: 45038822
• Report Number: 1719045-2016-10386
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 7312609
• Other Device ID Number: (010 07611819739208(10)7312609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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