• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES MONUMENT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH Back to Search Results
Catalog Number 319.006
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
There was no known reported patient involvement associated with the complained event. Date of event: unknown when device malfunctioned. Device is an instrument and is not implanted/explanted. A device history record (dhr) review was performed on part # 319. 006, lot # 6594366: release to warehouse date: feb 16, 2011, expiration date: na, manufactured by synthes (b)(4). Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product development investigation was performed. A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation. The depth gauge ((b)(4)) was returned in three pieces (slider, body, protection sleeve). The needle has broken off from the slider component and was not returned with the complaint. The condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material. There is a protection sleeve to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage. Replication of the complaint is not applicable as the complaint conditions were visually confirmed. This complaint is confirmed. The (b)(4) depth gauge is part of at least (b)(4) technique guides, including the 2. 4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2. 0mm/2. 4mm screws to ensure the correct screw length is used during the procedure per relevant technique guide. Relevant product drawings were reviewed. No drawing issues or discrepancies were noted. The design is adequate for its intended use and did not contribute to this complaint condition. The thickness of the needle is driven by the fact that the needle must fit into a drilled hole of 1. 5 mm, and the length is determined so the slider can measure screws up to 40 mm. The material of the needle probe component is extra hard, which is an appropriate material for an instrument component of this type. No new, unique, or different patient harms were identified as a result of this investigation. The design is determined to be adequate for its intended use when used and maintained as recommended. 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.
 
Event Description
It was reported that during the inspection of the tray, it was identified that the depth gauge is missing the probe portion of the item. No patient or case involvement. During the manufacturer investigation of the returned device it was identified that the needle has broken off from the slider component. This condition was re-evaluated and determined to be reportable on (b)(6) 2017. This report is for one (1) depth gauge for 2. 0mm and 2. 4mm screws. This is report 1 of 1 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Type of DeviceGAUGE,DEPTH
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6560879
MDR Text Key75018229
Report Number1719045-2017-10453
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.006
Device Lot Number6594366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-