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 Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.(b)(4).Device is an instrument and is not implanted/explanted.A service and repair evaluation was performed for the subject device.The customer reported the tip broke off.The repair technician reported ¿tip broken¿ as the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The service and repair evaluation was confirmed.The item was forwarded to synthes customer quality for additional investigation.Without a lot number a service and repair history record review and a device history record review could not be performed.The manufacturing date is 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 was reported that the tip of the depth gauge broke off during a tibial plateau leveling osteotomy (tplo) veterinary procedure on a canine on (b)(6) 2017.No fragments fell into the patient.Another depth gauge was readily available and was used to complete the procedure successfully with no delay.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

S&r service history review: 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.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified.The service and repair department documented the tip of the depth gauge broke off during a tibial plateau leveling osteotomy (tplo) procedure on a canine on (b)(6) 2017.No fragments fell into the patient.Another depth gauge was readily available and was used to complete the procedure successfully with no delay.Customer quality (cq) investigation: the depth gauge was received at cq disassembled in 5 pieces including the needle component which has sheared off at its base.A portion of the needle component is still retained in the slider body component.A visual inspection under 5x magnification, service history record (shr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Because the returned device does not have a lot # etched on it, it is determined that it is at least 10 years old and was manufactured prior to revision h which introduced lot# etch requirement/specification which was released on march 17, 2006.Malfunction most likely due to off-axis force applied to the needle which exceeded the shear strength of the needle on this 10+year old reusable instrument.This complaint is confirmed.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.

• 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: 6375188
• MDR Text Key: 68977356
• Report Number: 2520274-2017-10717
• 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,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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: 02/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• 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