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 Date 11/24/2015

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, as no product was received.A review of the device history records has been requested.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Service and repair department documented that during a scheduled open reduction internal fixation trimalleolar ankle fracture, as the surgeon was measuring screws for distal fibula in variable angle (va) plate, a depth gauge for 2.0mm and 2.4mm screws would not slide smoothly and kept getting stuck, making it difficult to measure the screw properly.This was discovered during a procedure.The surgeon was able to use an alternate depth gauge and successfully complete the surgery without time delay an no harm to patient.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Service history review: part no.319.006, lot no: unknown: no service history review can be performed because the lot number is unknown and cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.Date of report: initially reported as (b)(6) 2015; should be (b)(6) 2015.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

Part number: 319.006, lot number: 7430415: release to warehouse date: july 18, 2013.Manufactured by synthes (b)(4).No non-conformance reports were generated during production of this device assembly or the relevant components.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product investigation was completed: the returned depth gauge is severely worn with scratches and fading evident along the entire device.The hooked needle stem of the device is not broken off and is not bent.There is approximately 1.0-1.5mm of thread showing on the hooked needle.The device is calibrated correctly.The wear on the slider and body causes the device to not operate smoothly.This particular depth gauge is part many 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 cause for the complaint condition is likely due to wear over many years of use.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.Although the exact cause cannot be determined, the most probable root cause for this complaint is wear from use and repeated sterilization cycles over the life of the device.The design is determined to be adequate for its intended use when used and maintained as recommended.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: 5299009
• MDR Text Key: 33553259
• Report Number: 2520274-2015-17881
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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: 7430415
• Other Device ID Number: (01)10886982189943(10)7430415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2013
• 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