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 is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Service history record review: no service history review can be performed as part: 319.006 / lot: 7776371 is a lot/batch controlled item.The manufacture date of this item is september 2, 2014.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history record review: supplier: (b)(4).Manufacturing date: september 2, 2014 no non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.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.

Event Description

It was reported that a depth gauge was found in a broken condition on an unknown date with the needle portion missing.The issue was reported discovered following the cleaning process.No reported patient or surgical involvement.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the needle was broken.The repair technician reported the tip of the measuring device broke off, and the protective sleeve was missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.A product investigation was completed: one depth gauge (part 319.006, lot 7776371) was received for evaluation.The device shows regular use during its 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.This particular depth gauge is part of several 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 condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve to protect the needle during transport and the body that slides on the measuring portion adds additional protection to the needle attachment point during use.The exact cause could not be identified.This complaint is confirmed.The relevant drawings for the device(s) were 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 is extra hard 316ss, which is an appropriate material for an instrument component of this type.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Although the exact cause cannot be determined, the most probable root cause for this complaint is excessive force exerted on the depth gauge by placing / dropping heavy instruments on top of the device during the sterilization process.No manufacturing or design issues were noted during the investigation.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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5778318
• MDR Text Key: 49039038
• Report Number: 1719045-2016-10536
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• 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: 7776371
• Other Device ID Number: (01)10886982189943(10)7776371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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