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 Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Service history review: part no.319.006, lot no.6993842: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 26july2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown surgery, the following issues occurred with two different depth gauges.The tip of the first depth gauge came apart.This was not a revision surgery.There was no delay in the procedure; the surgeon had another device readily available for use.There was no reported harm to the patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The awareness date was reported as (b)(6) 2015 in error on the initial medwatch submission.The correct date of awareness for this complained event was (b)(6) 2015.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.

Manufacturer Narrative

Service & repair evaluation: the customer reported the tip came apart.The repair technician reported ¿tip broken¿ as the reason for repair.The item is not repairable.The cause of the issue is unknown.The item was forwarded to the complaint handling unit on (b)(4) 2015 for further evaluation.Product investigation summary: the returned depth gauge shows regular use during its lifespan.The hooked needle stem is broken off at the base of the black body (the broken stem is approximately 75mm in length) and was returned.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; it is likely due to wear or from damage during sterile processing.The relevant drawing for the device(s) was reviewed with no issues or discrepancies 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 is extra hard 316ss, which is an appropriate material for an instrument component of this type.Although the exact cause cannot be determined, the most probable root cause for this complaint is excessive force exerted on the depth gauge during use coupled with coupled with wear over the life of the device.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: 5213840
• MDR Text Key: 30874236
• Report Number: 1719045-2015-10726
• 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,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• 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: 6993842
• Other Device ID Number: (01)10886982189943(10)6993842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• 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