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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC

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DEPUY-SYNTHES SPINE ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Catalog Number 274641000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2017
Event Type  malfunction  
Manufacturer Narrative
Visual examination of the returned device revealed significant wear with the cutter fractured at the pivot point near the jaw. No other anomalies were detected. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. A trend analysis was conducted. No emerging trends were found requiring further actions. The root cause for the distal tip of the rod cutter becoming fractured cannot be positively determined. However, the noted damage suggests that the rod cutter jaw distal tip most likely was subjected to an unanticipated high load when cutting a rod resulting in a fractured jaw tip. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4). Awaiting sample: a follow up report will be filed upon completion of the investigation. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This instrument was used to cut the mountaineer rod when it suddenly broke.
 
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Brand NameROD CUTTER
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
DEPUY-SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY-SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6667365
MDR Text Key119385292
Report Number1526439-2017-10512
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number274641000
Device Lot NumberKM691775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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