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

Catalog Number 319.006

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the depth gauge for 2.00mm and 2.4mm screws is missing the silver ball from the inner sleeve.The event did not occur during surgery and there was no impact to a patient.No additional information will be made available.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implant and explant dates: device is an instrument and is not implanted/explanted.No service history review can be performed as this is a lot controlled item.The investigation could not be completed; no conclusion could be drawn, as the 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

Additional narrative: additional evaluation was conducted.The report indicates that the inner sleeve was missing the silver ball.The repair technician reported the stop ball was missing.The item is not repairable.The cause of the issue is unknown.A pd evaluation was conducted.The report indicates that the returned depth gauges show significant use during its lifespan.The hooked needle is intact, but the device is missing the ball bearing and spring.The depth gauge is part of 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.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide j8301-i.Drawing 319_006, rev.F for the device(s) was 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 miniature ball bearing is missing.The dimensions, material, and tolerances are within specification.The design is adequate for its intended use and did not contribute to this complaint condition.The most probable root cause for this complaint is excessive force exerted on the depth gauge or placing / dropping heavy instruments on top of the device during the sterilization process could have led to this complaint condition.The complaint is confirmed, and the design of the device did not contribute to this complaint.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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4245739
• MDR Text Key: 20975656
• Report Number: 2530088-2014-10369
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 5820037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1