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

Catalog Number 319.01

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).Lot # unknown.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Service history review was attempted for part# 319.01.No service history review can be performed because the lot/serial number is unknown and cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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

(b)(6) reported that during an ankle fracture repair on (b)(6) 2017, it was noted that three depth gauges from three synthes small fragment trays were sticking.The devices were also noted to have worn, bent tips.Over the past year, the devices were reportedly serviced due to periodic sticking.The devices were lubricated but are still noted to be sticking when depth is adjusted.Although there was a delay in the surgery due to the reported malfunctions, the length of for the delay is unknown.The surgery was successfully completed with an alternative, like device with no harm to the patient.There is no additional patient information available.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 3 of 3 for (b)(4).

• 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: 6280703
• MDR Text Key: 65855125
• Report Number: 2520274-2017-10292
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 319.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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