MAUDE Adverse Event Report: SYNTHES USA PEDICLE PROBE WITH PALM HANDLE FOR 4.0MM & 4.2MM SCREWS; MISC ORTHO SURGICAL INSTR

Catalog Number 388.536

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Sedation (2368)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

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.(b)(6).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 europe reports an event in (b)(6) as follows: the pedicle probe has no visible numbers, to verify screw length.The rod cutting to be used is disarmed, a hammer was used to take the piece of bar that would be used in the patient, the piece came out completely scratched and warped.The surgery time was extended for thirty (30) minutes.There was no patient harm.This is report 1 of 2 for com-(b)(4).

• Brand Name: PEDICLE PROBE WITH PALM HANDLE FOR 4.0MM & 4.2MM SCREWS
• Type of Device: MISC ORTHO SURGICAL INSTR
• 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: 5187763
• MDR Text Key: 29823106
• Report Number: 2520274-2015-16900
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/14/2015

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: 388.536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 10/29/2015
• 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
• Patient Age: 15 YR