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

Catalog Number 319.010

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/13/2013

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: this complaint was part of a market preference evaluation which records the complaint aspects of 2013 mpe results.It was reported the measurer tool has some interference inside the guide decreasing sensitivity when penetrating through soft cancellous head bone.One screw had to be removed and then placed again.The screws were not augmentable as intended, due to blockage of cannulation and due to risk for leakage into the joint.There was some cement back leakage in two screws.Some cement had to be removed to avoid head blockage.The patient had primary treatment on (b)(6) 2013, on three right fractures at the head and shaft between the lesser and greater tuberosity.The patient was (b)(6) years old or greater at the time of surgery.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.The patient was (b)(6) years old or greater.Device is an instrument and is not implanted / explanted.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3865341
• MDR Text Key: 4505454
• Report Number: 2520274-2014-11735
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 08/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1