MAUDE Adverse Event Report: SYNTHES JENNERSVILLE 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  

Event Description

It was reported that the depth gauge was discovered with the tip broken off during a routine maintenance inspection.There was no surgical or patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A service history review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Service history review: lot 7058666 - no service history review can be performed as this is a lot controlled item.The manufacture date of this item is october 15, 2012.The source of the manufacture date is the release to warehouse date.Service & repair evaluation: the customer reported the tip broke off.The repair technician reported tip broken as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on june 29, 2015 for further investigation.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 the tip of a depth gauge for 2.0mm and 2.4mm screws broke off.Also, a handle with mini quick coupling would not connect.It was later discovered that a piece of another object had broken off inside of the nose piece.The reported fragment did not have a lot number.These events were discovered during routine set checks for maintenance.No patient or surgical involvement.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number, 319.006, depth gauge for 2.0mm and 2.4mm screws).The subject device was received with the complaint of ¿tip has broken off.¿ the returned depth gauge for 2.0mm and 2.4mm screws was received with minor superficial damage on the surface, but the needle was completely broken off of the body of the gauge.The depth gauge for 2.0mm and 2.4mm screws was manufactured on oct 15, 2012 and relevant drawing at the time of manufacture was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The depth gauge for 2.0mm and 2.4mm screws did not exhibit signs of abuse and although a true root cause could not be determined it is likely that the complaint condition is due to the gauge being used without the protection sleeve and/or the needle being used in an unintended manner which exposed the needle to bending forces which eventually caused the needle to break away from the body of the gauge.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 JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4870272
• MDR Text Key: 5866130
• Report Number: 2530088-2015-10497
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 319.006
• Device Lot Number: 7058666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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