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

Catalog Number 314.743

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted or explanted.(b)(4) unintended intra-operative x-rays.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing date: february 12, 2014.No non-conformance reports 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.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 reported that a reamer/irrigator/aspirator (ria) drive shaft became stuck in the ria assembly tube during a ria bone graft harvest and hind-foot fusion procedure with intramedullary nailing.The ria system was inserted into the talus from the hindfoot.At that point, the ria stopped its forward progression into the talus.The surgeon used a mallet on the back of the ria's drill power in an attempt to advance the system.The ria did not advance.The ria system was then pulled back and removed.A cannulated drill was inserted up to the talus to create a pathway for the ria.The ria was reinserted past the talus into the tibia and reaming proceeded without further complication.A satisfactory amount of bone graft harvest was acquired.At the end of the procedure, the scrub tech could not remove the ria drive shaft from the ria tube assembly.Then, during the proximal screw targeting & drilling procedure, the 4.2mm drill was hitting the most proximal hole for 12x240mm nail.Observation of drill-nail collision was noted by sound and feel.The surgeon used the power's oscillation mode to advance past the nail.The drill passed through the nail and the 5.0mm screw was inserted without further problems.At the end of the procedure, the scrub tech could not remove the insertion handle from the aiming arm.A mallet was used on the insertion handle in an attempt to loosen.A fin broke off the insertion handle, which allowed for the handle to be disengaged from the aiming arm.The procedure was successfully completed with a one (1) minute surgical delay as the surgeon needed to take additional x-ray images in order to remove the ria and prepare for the extra drilling.The patient's post-procedural status/outcome was reported to be "as expected." this report is 1 of 4 for (b)(4).

Manufacturer Narrative

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

Additional information: upon receiving the devices, it was identified that the reamer head is also stuck with the drive shaft and ria assembly.This report is 1 of 5 for (b)(4).

Manufacturer Narrative

Device investigation summary ¿ one drive shaft, minimum 520mm length, for use with reamer/irrigator/aspirator (ria) (part number 314.743, lot number 7432391), one ria tube assembly, min 520mm length, for 314.743 (part number 314.746s, lot number 7802335), and one 12.5mm reamer head for ria (part number 352.251, lot number unknown) were received with the reported condition that the ria stopped forward progression in the talus and that at the end of the procedure, the scrub tech could not disassemble the devices.One aiming arm for titanium cannulated hindfoot arthrodesis nail-expert (part number 03.008.009, lot number 1842861) and one insertion handle for hindfoot arthrodesis nail-expert (part number 03.008.007, lot number 1501821) were received with the reported condition the 4.2mm drill was hitting the most nail and that at the end of the procedure a fin broke off the insertion handle because a mallet was used as the scrub tech could not remove the insertion handle from the aiming arm.The complaint condition is confirmed overall.It was confirmed that the drive shaft, reamer head, and tube assembly were stuck together and that the insertion handle was broken.However, the misalignment and the sticks/jams/stuck condition of the insertion handle and aiming arm could not be confirmed as they could not be replicated.While it could not be definitively determined, based on the returned condition of each device, it is most probable that the method of use resulted in the complaint conditions.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The related product drawings were reviewed.It was found that the returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.There were no findings dhr reviews that would contribute to the compliant conditions.Part numbers 314.743, 314.746s, and 352.251: the technique guide describes how standard opening procedures and instrumentation should be used to gain access to the intramedullary canal.Based on the description that the surgeon used a mallet on the back of the ria¿s drill power in an attempt to advance the system and that after hammering would not advance the system a cannulated drill was inserted up to the talus to create a pathway for the ria, it is most probable that insufficient opening and excessive force result in the jammed 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 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: 5131287
• MDR Text Key: 27768573
• Report Number: 1719045-2015-10647
• 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
• Type of Report: Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 7432391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR