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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH 8.5MM MEDULLARY REAMER HEAD

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SYNTHES SELZACH 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problems Break; Material Fragmentation
Event Date 02/09/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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

Device report from synthes eu reports an event in (b)(6) as follows: during surgery, while the surgeon was reaming the intramedullary canal, the reamer head broke. There was a reported fifteen minute surgical delay to surgery. This is report 1 of 1 for com-(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 - the broken fragments were left in the patient. There was no re-operation needed.

 
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.

 
Manufacturer Narrative

Additional narrative: subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device history record review: manufacturing location: (b)(4) - manufacturing date: december 4, 2012 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 the product that would contribute to this complaint condition. Corrected data: the awareness date was inadvertently changed to (b)(6) 2016 on the second supplemental report. The event date was (b)(6) 2016, but the awareness date was (b)(4) 2016. 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.

 
Manufacturer Narrative

Additional narrative: product investigation summary: the received reamer head is broken apart at the end of the coupling hexagon as complained. Furthermore, there are stress marks behind the cutting edges, which are also worn. Not all fragments from the broken part were returned for evaluation. Due to the damage of the device, the relevant dimensions could not be verified. However, no non-conformance records were generated during production, as confirmed during the device history record review. There were no issues during the manufacture of the product that would contribute to this complaint condition. Based on the provided information, the manufacturer is unable to determine an exact root cause; however, it is likely that a mechanical overload situation led to the damage of the received device. No product fault could be detected. 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.

 
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Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach PA CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5467282
Report Number2520274-2016-11377
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
Device LOT Number27180
OTHER Device ID Number(01)07611819243699(10)27180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/04/2012
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: 02/29/2016 Patient Sequence Number: 1
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