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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MESH CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC

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SYNTHES TUTTLINGEN MESH CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC Back to Search Results
Catalog Number 391.952
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2017
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Additional narrative: 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. (b)(6). A service history evaluation/review was attempted. The investigation of the complaint articles has shown that: a (b)(4) service history review for part #391. 952, lot #t976156 need to be completed. The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
(b)(6) reported the following event: during an unknown surgery on (b)(6) 2017, a small piece of the end of the mesh cutter broke off. It was reported that the piece was retrieved and no fragments remain in the patient. There was no delay in surgery as the procedure was completed with a similar device. The patient was reported as stable and the surgery completed successfully. This complaint is for one device. Concomitant device: mesh (part #unknown, lot #unknown, quantity unknown). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
No service history review can be performed as part number 391. 952 with lot number(s) t976156 is a lot/batch controlled item. The manufacture date of this item is may 31, 2012. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. Manufacturing date: may 29, 2012. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records. All parts of the lot were checked 100% for important features and for function at the final inspection. No non-conformance reports were generated during production. A service and repair evaluation was completed: the customer reported the end of the mesh cutter broke off. The repair technician reported that one of the tips was broken off and missing, and the second tip was cracked and coming apart. Tip broken is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. 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
Product development investigation was completed. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. A visual inspection at customer quality determined that one of the tips has broken off and is missing, and the second tip is cracked and is coming apart. The material surface at the location of breakage appears homogeneous when viewed under 5x magnification. Relevant drawings were reviewed. No product design issues or discrepancies were observed. Root cause could not be determined at customer quality. No new, unique or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. No new malfunctions were identified as a result of the investigation. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. 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 NameMESH CUTTER
Type of DeviceINSTRUMENT,CUTTING,ORTHOPAEDIC
Manufacturer (Section D)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6443271
MDR Text Key71223594
Report Number9680938-2017-10054
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
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
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391.952
Device Lot NumberT976156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/29/2017 Patient Sequence Number: 1
Treatment
MESH - PART #UNKNOWN, LOT #UNKNOWN, QUANTITY UNK
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