MAUDE Adverse Event Report: SYNTHES MONUMENT PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM; MONITOR, PRESSURE, INTRACOMPARTMENT

Catalog Number 530.412

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Additional patient information: patient height reported as (b)(6).Patient initials are (b)(6).(b)(4).Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing date: july 8, 2014 - manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 a compartment pressure monitoring probe failed to read during an external fixation procedure of a bilateral tibia on (b)(6) 2016.The device was slid into the intravenous catheter and then pulled back to expose the probe, but not reading was registered.After about thirty (30) seconds, the device read ¿probe malfunction.¿ the device was then retrieved and an arterial line used to pass through in order to obtain the reading.As a result, there was a five (5) to eight (8) minute delay.At the time of the report, the procedure was still in process, but said to be successful.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The awareness date on the initial medwatch was entered as june 20, 2016 in error.The correct date of awareness was january 20, 2016.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.

Manufacturer Narrative

Manufacturing investigation evaluation: the reported chip was not cleaned after use.The customer report that the cpms probe ((b)(4)) had no reading at all.The monitoring unit said probe malfunction after thirty (30) seconds.As soon as the device malfunction was realized, the surgeon retrieved an arterial line and passed the line through to get a reading instead.The issue was confirmed.The probes were sent to mipm mammendorfer institute for evaluation and found to display an error, which was due to the chip not being properly cleaned after use.Since the device failure was caused by user misuse/abuse and is not related to any device nonconformity or manufacturing process failure, no further investigation is required at this time.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.

• Brand Name: PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM
• Type of Device: MONITOR, PRESSURE, INTRACOMPARTMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5434169
• MDR Text Key: 38751129
• Report Number: 1719045-2016-10128
• Device Sequence Number: 1
• Product Code: LXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2016

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: 530.412
• Device Lot Number: US-29-2131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2016; 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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 Age: 62 YR
• Patient Weight: 110