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); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Service and repair evaluation: the customer reported the tip was missing; the repair technician reported the tip broke off and 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 for further investigation.Product investigation summary: one (1) depth gauge (part: 319.006 / lot: 7368773) was returned for investigation in multiple pieces.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.The slider is loose in the hollow body.The handle has various marks/scratches and the laser marking on the shaft is clearly visible.The condition of the depth gauge is consistent with the result of a bending force being 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 a body that slides on the measuring portion to provide additional protection to the needle attachment.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.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.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 relevant drawings were reviewed with no drawing 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 (1.25mm) is driven by the fact that the needle must fit into a drilled hole of 1.5mm; the length (80mm) is determined so the slider can measure screws up to 40mm.The material of the needle probe component is extra hard 316ss, which is an appropriate material for an instrument component of this type.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.Service history record review: no service history review (shr) can be performed as the device is a lot/batch controlled item.The manufacture date of this item is may 2, 2013 (release to warehouse).The shr is unconfirmed.Device history record review: manufacturing location: (b)(4) - manufacturing date: may 2, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the 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 originally reported that a depth gauge for 2.0mm and 2.4mm screws was missing a few parts.The issue was reportedly found during assembly and was not associated with a specific patient or procedure.Upon visual inspection of the complained device by the service and repair technician, which was completed on (b)(6) 2016, it was noted that the tip of the device had broken off.Further investigation identified that the device was actually broken into multiple pieces.As such, the device was re-assessed and found to meet reportability criteria.This report is 1 of 1 for (b)(4).

• 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: 5908260
• MDR Text Key: 53279049
• Report Number: 1719045-2016-10644
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• 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: 7368773
• Other Device ID Number: (01)10886982189943(10)7368773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• 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