MAUDE Adverse Event Report: SYNTHES USA DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T

Catalog Number 319.006

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: in the operation on (b)(6), when using depth gauge f/scr ø1.3+1.5 sst of modular hand system, the tip of the depth gauge broke off.The surgeon said, the breakage occurred after taking the tip in and out repeatedly, because the tip was bent from the beginning, no broken part was left in the patient.This is 1 of 1 report for complaint (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.Manufacturing documents were reviewed and no complaint related issues were found.The part was received and the investigation is ongoing.Placeholder.

Manufacturer Narrative

The product development evaluation reported the measuring needle broke off and hasn¿t been returned.The device has possibly been used nearly 2 years.Wear and inappropriate usage may have led to the breakage.

Manufacturer Narrative

A manufacturing evaluation was performed on the returned product (depth gauge for 2.0mm and 2.4mm screws).The needle component is broken off flush with the end of the slider assembly and the needle component was not retuned.The finish on body component is in poor condition.The slider and handle have visible scratches and nicks on the surface.A complete evaluation is not able to be performed due to the missing needle component; therefore this complaint is deemed indeterminate from a manufacturing perspective.

• Brand Name: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T
• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3633289
• MDR Text Key: 3991627
• Report Number: 2520274-2014-00633
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2014

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: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 6858549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2014; 08/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1