MAUDE Adverse Event Report: SYNTHES MONUMENT ROD INTRODUCER; MISC ORTHO SURGICAL INSTR

Catalog Number	03.616.048
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional 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).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 or Problem Description
(b)(6) reported during a lumbar minimally invasive surgery (mis) fusion at unknown levels on (b)(6) 2017, while surgeon was attempting to insert the second rod it was noted the rod introducer was not holding the rod properly.Surgeon was able to complete the procedure successfully utilizing the device with no delay and no harm to patient concomitant medical products: rod( part number unknown, lot number unknown, quantity 1).This report is for one (1) rod introducer.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device recieved april 12, 2017.Dhr review for part# 03.616.048 lot# 6970075 release to warehouse date: 12nov2012.Additional release to warehouse dates: 24oct2014, 09jun2015.No ncrs 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Investigation methods/evaluation results: a product evaluation was performed.The investigation of the complaint articles indicates that : the rod introducer is a component of the matrix mis standard instrument set (01.616.016) and can be utilized in matrix mis (minimally invasive) procedures for thoracolumbar pedicle fixation.The rod introducer is one of two devices utilized for rod placement; the alternative device is the rod forceps (03.616.053).The returned rod introducer was examined and the distal tip was found to be worn, the compression spring is worn as it no longer holds its position as intended.The rod introducer was tested with a known good minimally invasive curved rod (04.651.300 lot 3581700) and the complaint condition could be replicated as the device was unable to retain and articulate the rod as intended.This complaint is confirmed.Relevant drawings for the returned rod introducer were reviewed (both current revision and from the time of manufacture.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Note three on the drawing for the ratcheting handle states the following: ¿instrument must be capable of ratcheting in either direction and have a locked position.The device must be capable of sustaining a minimum torque of 15nm in any mode without slipping.¿ the design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments¿ lot numbers and no mrrs, ncrs or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.No definitive root cause could be determined as the circumstances surrounding the complaint are unknown.During the investigation, no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: ROD INTRODUCER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6461808
• Report Number: 1719045-2017-10288
• Device Sequence Number: 591771
• Product Code: LXH
• UDI-Device Identifier: 10705034716381
• UDI-Public: (01)10705034716381(10)6970075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.616.048
• Device Lot Number: 6970075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/14/2017; 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD (PART AND LOT NUMBER UNKNOWN, QUANTITY 1)