MAUDE Adverse Event Report: SYNTHES USA DEPTH GAUGE FOR LARGE SCREWS; GAUGE, DEPTH

Catalog Number 319.100

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient age/date of birth and weight are unknown.Date of event: unknown date in (b)(6) 2015.(b)(4) lot unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).This report is related to mfr report number 2520274-2016-12217.That report captured the entire complained event focusing specifically on the plate breakage due to the complaint against the depth gauge.On may 20, 2016, it was determined the depth gauge involved in the complained event should be reported on a separate medwatch report.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.A product development evaluation was completed: as the part has not been returned to the company, the complaint situation could not be replicated and the limited provided information does not allow identifying a final root cause.Furthermore, as the lot number of the instrument was not available, no manufacturing information could be verified.A functional test of a depth gauge available at the company was performed; the complaint situation could not be replicated.Device was 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

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that the patient underwent revision surgery on an unknown date in (b)(6) 2015 due to an unknown fractured plate.It was also reported that the unknown screws used to fixate the plate were, in the surgeon's opinion, 3mm too short.It was further reported that the patient has suffered chronic injury due to the reported event.The patient's injury was translated from dutch as a "permanent tilt' or "inclined position." the patient was initially implanted on an unknown date in (b)(6) 2015 to treat a humeral fracture.This report is to address the malfunction of the depth gauge in (b)(6)2015 which resulted in screws that were too short being implanted in and may have contributed to the plate breaking.Related (b)(4) address an additional event from the (b)(6) 2015 revision.This is report 2 of 2 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LARGE SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5670113
• MDR Text Key: 45616168
• Report Number: 2520274-2016-12784
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 05/20/2016
• 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
• Patient Outcome(s): Required Intervention