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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743 REAMER

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SYNTHES SELZACH RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743 REAMER Back to Search Results
Catalog Number 314.746S
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2017
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. Patient information not available for reporting. Other udi: (01) unknown (10) lot unknown, udi is unavailable. This report is for unknown reamer/irrigator/aspirator /unknown lot number. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. The 510k#: is unknown. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 on an event in (b)(6) as follows: it was reported that reamer/irrigator/aspirator broke off under the reamer head. No patient harm reported. There was a surgery prolongation of 30 minutes reported. This complaint involves 1 part. 1x unk reamer head, part/lot unknown. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Patient information not available for reporting. Device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. 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 NameRIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6908273
MDR Text Key88077016
Report Number2520274-2017-12373
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number314.746S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated By Manufacturer? Yes
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: 10/02/2017 Patient Sequence Number: 1
Treatment
1X UNK REAMER HEAD, PART/LOT UNKNOWN
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