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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 Problems Break; Device Operates Differently Than Expected
Event Date 08/14/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review ¿ (b)(4) manufactured the drive shaft - minimum 520mm length ¿ for use with ria (reamer / irrigator / aspirator) p/n 314. 743, lot # 7432392, dated february 19, 2014. The certificate of compliance and the certificate of conformance, indicated the lot was manufactured and conformed to specifications. The lot was inspected and conformed to the synthes incoming final inspection sheet. There were no mrr, ncrs, or complaint-related issues with this lot. Parts were released to the warehouse on february 25, 2014. 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

It was reported that a reamer irrigator aspirator shaft broke during surgery on (b)(6) 2015. The close tube clip which covers drive shaft and tube assembly, popped off. There was reportedly no delay to surgery and all parts were safely removed. There is no further information at this time. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

A product evaluation was performed. The investigation of the complaint articles indicates that the one drive shaft, minimum 520mm length, for use with reamer/irrigator/aspirator (ria) (part number 314. 743, lot number 7432393) was received with the complaint category of ¿broken: intraoperatively. ¿ the complaint condition is confirmed for the drive shaft as it was received with the distal tip broken off. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. Specific details regarding the technique used/handling which led to the device failure were not provided, however it is most probable that excessive force and/or use of an incorrect drive unit repeatedly over torqued the drive shaft leading to fatigue and ultimately the fracture at the distal tip. The unexpected fracture likely subsequently resulted in the disengagement of the locking clip, 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.

 
Manufacturer Narrative

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. A second device history records was conducted. The report indicates that the: criterion tool & die manufactured the drive shaft, minimum 520mm length, for use with ria, p/n 314. 743, lot # 7432393, per po # 1566904, dated (b)(4) 2014, for 49 parts. The lot conformed to specifications as noted in the certificate of compliance, dated march 18, 2014. The drive shaft was inspected and conformed to the synthes incoming final inspection tabulated sheet # 314if741, revision ¿m¿. There were no complaint-related issues, mrrs, or ncrs associated with this lot. 49 parts were released to the warehouse on april 07, 2014. The drive shaft was manufactured to the synthes tabulated drawing number 314. 741, revision ¿k¿, released on march 29, 2011 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
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5034955
Report Number1719045-2015-10546
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number314.743
Device LOT Number7432393
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/27/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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