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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER Back to Search Results
Catalog Number 314.743
Device Problem Material Fragmentation
Event Date 09/15/2016
Event Type  Injury  
Manufacturer Narrative

Device is an instrument and is not implanted/explanted. (b)(4). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Part: 314. 743, lot: 6718729, release to warehouse date: 17-jan-2012, 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

It was reported the tip of a reamer irrigator aspirator (ria) drive shaft broke in multiple pieces during surgery on (b)(6) 2016. While reaming the femoral canal for graft with the ria, the tip of the drive shaft broke into multiple pieces. This occurred after the full length of the femur had been reamed. The surgeon began to pull back on the ria, simultaneously freeing the drive shaft from the ria reamer head. The surgeon reversed the drill, spinning the disengaged drive shaft, likely breaking the drive shaft when it came in contact with the reamer head. The broken pieces were easily removed, having been captured inside the tube assembly. Additional x-rays were taken to confirm there were no metal fragments inside the femoral canal. There was a two (2) to three (3) minute surgical delay. The procedure was completed successfully with no harm to the patient. Concomitant device reported: reamer head (part# unknown, lot # unknown, quantity 1) this is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

A product development investigation was performed for the subject device (drive shaft-minimum 520mm length-for use with ria part # 314. 743, lot number 6718729). The subject device returned with the complaint condition stating as the distal tip of a drive shaft for ria (314. 743) broke while attempting to remove the ria assembly following the completion of reaming. The returned device was examined and the complaint condition was able to be confirmed as the distal tip of the drive shaft was found to be broken and missing a segment (approximately 13mm long and 5mm in diameter). During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection and drawing review were performed as part of this investigation. This complaint is confirmed. The drive shaft for ria is a component of the reamer/irrigator/aspirator (ria) system which is utilized for intramedullary reaming and bone harvesting. No definitive root cause was able to be determined. Based on the complaint description it appears that the drive shaft became disengaged during attempted instrument withdraw, following the completion of reaming, which allowed the rotating drive shaft to contact the stationary reamer head. The surgical technique guide provides the follow instructions for removal of the ria assembly follow reaming: after the reamer head reaches the desired depth, withdraw the ria assembly while maintaining rotation of the drill. Note: reverse the drill if advancement of the reamer becomes difficult. Relevant drawings for the returned device were reviewed. Relevant dimensions on the distal end of the device were checked near the break and were compared to the prints at the time of manufacture and the returned instrument was found to be within specification. The design, materials and finishing processes were found to be appropriate for the intended use of this device. No definitive root cause was able to be determined. Based on the complaint description it appears that the drive shaft became disengaged during attempted instrument withdraw, following the completion of reaming, which allowed the rotating drive shaft to contact the stationary reamer head. During the investigation no product design issues or discrepancies were observed that may have contributed 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.

 
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Brand NameDRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5987451
Report Number1719045-2016-10721
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number314.743
Device LOT Number6718729
OTHER Device ID Number(01)10886982189042(10)6718729
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/28/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/29/2016 Patient Sequence Number: 1
Treatment
REAMER HEAD, PART: UNKNOWN
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