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

Catalog Number 319.006

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A service history record review was attempted for the subject device; however, the review could not be performed because the device is a lot-controlled item.The manufacture date of this item is 7-sep-2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.The subject device has been received and is currently in the evaluation process.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 the tip of the depth gauge for 2.0mm and 2.4mm screws broke off.The reported issue was discovered after sterilization and was not associated with a surgical procedure.It was confirmed there was no patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the tip was broken.The repair technician reported tip broken as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: the returned depth gauges shows regular use during its 13+ year lifespan.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approximately 75mm in length) and was not returned.Per the technique guide, 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.Although the damage appears to be the result of excessive weight being placed onto the needle during sterile processing and does not appear to be the result of normal use; the exact cause could not be identified.This complaint is confirmed.The relevant drawing 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 thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle probe is (b)(4), which is an appropriate material for an instrument component of this type.The design is adequate for its intended use when used and maintained as recommended, it did not contribute 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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE,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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5191663
• MDR Text Key: 29972355
• Report Number: 1719045-2015-10704
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6760018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• 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