MAUDE Adverse Event Report: SYNTHES MONUMENT PROBE

Catalog Number 388.54

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.(b)(4), lot number unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Hospital contact telephone not available for reporting.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.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 (b)(4) reports an event in (b)(6) as follows: it was reported the tip of two (2) separate probes broke during a spinal fusion revision on (b)(6) 2017.Patient was initially implanted with the uss1 construct in 2014 and was returned to surgery on (b)(6) 2017 to extend the construct by one level.Reason for revision is not known.The two (2) bilateral rods from t10 -s1 were removed and replaced, extending to t9.Two (2) screws, two (2) nuts, and two (2) polyaxial heads were also added to the construct.While surgeon was inserting the left rod and the last (9th) corresponding polyaxial head, the surgeon engaged the probe, with the collar loaded, and the tip of the probe broke off.Surgeon continued placing the right rod and, while inserting the second probe and the 9th polyaxial head, the second probe broke in the same fashion as the first.The broken fragments did not fall into the surgical field.Surgeon utilized a third, alternative device to complete the procedure.Surgery was completed with a delay of approximately 8 minutes and no harm to patient.Revision surgery is addressed in (b)(4).This report addresses the intraoperative event regarding the probes.Concomitant devices reported: rod (part number unknown, lot number unknown, quantity 2), polyaxial head (part number unknown, lot number unknown, quantity 2), collar (part number unknown, lot number unknown, quantity 2).This report is for one (1) probe.(b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: PROBE
• Type of Device: PROBE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6828325
• MDR Text Key: 85280304
• Report Number: 1719045-2017-10855
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• 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