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

Catalog Number 319.006

Device Problem Break (1069)

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the service history records has been requested.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 the bearing inside a depth gauge for 2.0mm and 2.4mm screws broke and fell off during a case.Another depth gauge was available to complete the case with no negative impact to the case or patient.No delay in surgery reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Synthes manufacturing location was discovered upon receipt of subject device.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

Update: 09/29/2015, per sales consultant, an issue was observed with the depth gauge during a case; however the exact problem was later identified postoperatively, during sterilization of the set.

Manufacturer Narrative

Service history review: part no: 319.006, lot no: 6944260: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 17may2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the bearing inside the item broke.The repair technician reported the tip was bent at the threaded end of the probe, and the tension ball was missing.Bent is 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.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.

Manufacturer Narrative

Product investigation summary: one of the following was received: depth gauge (part 319.006 | lot 6944260).The returned depth gauge shows regular use during its 3+ year lifespan.The hooked needle stem of the device is severely bent and the ball bearing is missing from the side of the graduated slider.It is unknown what caused the complaint condition.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.Although the bent needle 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 of the missing component 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 component (part 319.006.03) is extra hard 316ss, 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.An expiration date was reported for this device on the first follow up medwatch.This device is non-sterile and does not have an expiration associated.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: 5100033
• MDR Text Key: 26629078
• Report Number: 2520274-2015-16101
• 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: Followup
• Report Date: 09/11/2015

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: 6944260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• 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