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

Catalog Number 319.006

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn,.Service history review was attempted: part no.319.006, lot no: 6823060, no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 28-nov-2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department documented that during a fifth metatarsal open reduction internal fixation surgery the depth gauge for 2.0mm and 2.4mm screws was sticking and not sliding properly.A back up depth gauge for 2.0mm and 2.4mm screws was used to complete the surgery successfully, but later in sterile processing the back up was found to be experiencing the same issue, sticking and not sliding.There are 2 parts for this complaint.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and an investigation summary was performed.The investigation of the complaint articles has shown that: the following was received: depth gauge (part # 319.006 | lot # 6220623), depth gauge (part # 319.006 | lot # 6823060), the returned depth gauges shows regular use during its lifespan.The hooked needle stem of the devices are not broken off at the base of the black body, nor are they loose.The devices are calibrated correctly.Both devices exhibit some resistance to movement, causing the sliding action to not be smooth.This particular depth gauge is part of at least 14 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.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.The exact cause for the damage could not be determined, but it is likely due to wear from use and repeated sterilization cycles over the life of the device.No manufacturing or design issues were noted during the investigation.The design determined to be adequate for its intended use when used and maintained as recommended.This complaint is confirmed.This investigation summary is approve.A service & repair history/maintenance review was performed.The investigation of the complaint articles indicates that: the customer reported the item was sticking and not sliding properly.The repair technician reported the item had mineral buildup inside.Binding is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit.The evaluation was confirmed.Device 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: 5265547
• MDR Text Key: 32661028
• Report Number: 1719045-2015-10788
• 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: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• 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: 6823060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2011
• 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