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 08/20/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) 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 that the patient had surgery on (b)(6) 2013 on four right fracture planes at the head and shaft between the greater and lesser tuberosity.This patient had a displaced valgus impacted fracture; the patient was 80 years old or greater at the time of surgery.There was an anatomic surgical neck fracture and the cancellous bone of the head fragment was not deep enough to be held with screws purchasing bone 8mm from the subchondral bone.There was poor handling of the length probe and measuring of the screw length.Also, poor handling and injection of the contrast fluid that leaked back while being injected in many times.Both a and e cannulated screws were used but contrast penetrated into the anatomic neck fracture line first and then into the joint space afterwards.There was difficulty for posterior interpretation of x-rays.No screws were able to be cemented.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.The patient was (b)(6) or greater at the time of surgery.Device is an instrument and is not implanted / explanted.Investigation is on-going.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.Review of manufacturing records has been requested.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 east wrights lane; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3884959
• MDR Text Key: 4545822
• Report Number: 2520274-2014-11743
• 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: 12/12/2013

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: 319.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 06/19/2014
• 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