MAUDE Adverse Event Report: SYNTHES (USA) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.04

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.A service and repair evaluation was completed for the subject device.The customer reported the device was broken.The repair technician reported the tip of the measuring device broke off, and the device did not have a lot number etched on it.¿tip broken¿ is the reason for repair.The device is not repairable per the inspection sheet.The cause of the issue is unknown.The service and repair evaluation was confirmed.The device was be forwarded to customer quality for additional investigation.The results are pending completion and will be submitted in a supplemental report.Without a lot number the device history records review could not be completed.The synthes manufacturing location and date of manufacture are unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported that the depth gauge was discovered broken in central processing on (b)(6) 2016.It is not known when the device was broken.There was no reported patient or procedural involvement associated with the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the depth gauge (part number 319.04, lot number unknown).The subject device was returned with the complaint condition stating the measuring hook was found to be completely broken off of the slider and was bent at the distal tip.A portion of the threaded section of the measuring hook remains in the slider, but does not protrude from the slider.The remainder of the device was found to be in good condition with minor surface wear which does not impact functionality.The complaint is confirmed.No service history review or device history review can be performed because the lot/serial number is unknown.The manufacture date is unknown.A visual inspection and drawing review were performed as part of this investigation.The diameter of the measuring hook was measured to be 1.57mm which is within the specification of 1.6mm +0/- 0.05.No definitive root cause was able to be determined.The complaint condition 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.The sleeve and headpiece, which slide on the calibrated portion, add additional protection to the needle attachment point during use.Thus, it is likely that the issue occurred while disassembled for sterilization.However, given the unknown conditions at the time of the breakage the root cause could not be definitively determined 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 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6125490
• MDR Text Key: 60877556
• Report Number: 2520274-2016-15493
• 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,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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