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 Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implant date: date of original implant, unknown.(b)(4).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 for part# 314.743, supplier lot# 15020-01 synthes lots# 5588728 and 5585069, release to warehouse date: (b)(6) 2007 supplier ¿ criterion tool and die, packaged by ¿ synthes: (b)(6) 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.The supplier lot number was split into two synthes lots: 5585069 ((b)(4) parts released (b)(6) 2007) and 5588728 ((b)(4)part released (b)(6) 2007).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 a reaming irrigation aspirator (ria) drive shaft snapped while being backed out of femoral canal.Fragments were generated and removed from the patient.There was a two minute surgical delay due to fragment removals.The patient status is stable.The procedure was completed successfully.This complaint involves one device.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

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.

Event Description

It was further reported that the procedure was performed under routine fluoroscopy with routine intra-operative x-ray imaging.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).A product development investigation was performed for the subject device (drive shaft-minimum 520mm length-for use with ria, part number 314.743, supplier lot number 15020-01, synthes lot numbers 5588728 and 5585069).The subject device was received for the complaint category of ¿broken: intraoperatively.¿ it was reported that fragments were generated and removed from the patient and that there was a two minute surgical delay due to fragment removals.The drive shaft was received with the distal tip, which mates with the reamer head, broken off.The broken portion was not received.However, it was reported that the fragments were removed from the patient.The break is roughly transverse and located within 3.4mm to 7mm from the distal edge of the drive shaft helix.The helix is significantly scraped and worn down.The proximal connecting post shows scraping and worn edges.Thus, the complaint condition is confirmed and consistent with the reported condition but cannot be replicated as the shaft is already broken.The current relevant drawings for the returned device were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument¿s lot number and no complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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.(reamer/irrigator/aspirator (ria) technique guide).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.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.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.Device is an instrument and is not implanted/explanted.(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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5485978
• MDR Text Key: 39877546
• Report Number: 1719045-2016-10203
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 15020-01
• Other Device ID Number: (01)10886982189042(10)15020-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• 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