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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 Problem Material Fragmentation
Event Date 01/30/2016
Event Type  Injury  
Manufacturer Narrative

Device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn as no product was received. Device history record review: manufacturing location: (b)(4) - manufacturing date: october 15, 2010. 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. 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 patient underwent a tibial nailing procedure on (b)(6) 2016 to treat a closed mid-shaft tibia fracture. During the procedure, the tip of an 8. 5mm medullary reamer head broke off. The breakage was discovered while the surgeon was confirming the tibial nail insertion depth. The generated reamer fragments were left in the patient. The procedure was completed without delay or further incident. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Additional 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

A product investigation summary evaluation was performed. The investigation of the complaint articles indicates that the: it was reported that an 8. 5mm medullary reamer head (352. 085 lot 24917 mfg 15oct2010) broke while reaming during a mid-shaft tibial fracture nailing procedure. The fragments were not retrieved and the procedure was completed without surgical delay. The returned device was examined and the complaint condition was able to be confirmed as approximately 2mm of the distal end of the reamer head was found to be missing. Further inspection under magnification revealed that the cutting edges were chipped/gouged in a manner consistent with 5+ years of use. 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 Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5442928
Report Number3000270450-2016-10032
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
Device LOT Number24917
OTHER Device ID Number(01)10886982194176(10)24917
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2010
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: 02/17/2016 Patient Sequence Number: 1
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