MAUDE Adverse Event Report: SYNTHES MONUMENT NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA; NEUROLOGICAL STEREOTAXIC INSTR

Catalog Number	03.632.316
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: olo.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
It was reported that during an anterior lumbar interbody fusion (alif) and posterior spinal fusion procedure on (b)(6) 2017 from l4 to s1, a small piece of the quick coupling attachment sheared off during impaction.There was a 10 minute delay; the surgery was completed with no reported harm to the patient.There were no reported fragments in the patient.This report is for one (1) navigable handle this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed on part # 03.632.316, lot # 6975892: release to warehouse date: 03-jul-2013, 17-jul-2013, 03-dec-2013, 07-mar-2014, expiration date: n/a, supplier: (b)(4).Review of the device history record showed that there are potential issues during the manufacture of this product that would contribute to this complaint condition.A product development investigation was performed.The following complaint device(s) was received by customer quality (cq): one navigable handle for use with access cannula (part number: 03.632.316, lot number: k122211, mfg date: 03jul2013).A visual inspection and device history review were performed as part of this investigation.The returned instrument was examined and the complaint condition could be confirmed as the trocar lock has broken off from the button pin.Replication of the complaint condition is not applicable as it¿s already broken.Balance of the device is in fair condition.This complaint is confirmed.The returned instrument is part of the synthes navigated instruments for matrix and matrix mis spine systems.The instrument is utilized in the with the inner shaft (03.632.313) and pedicle access cannula shaft (03.632.322) to perforate the cortex of the pedicle prior cannulated screw insertion per relevant technique guide.Relevant drawings for the returned instrument were reviewed.No definitive root cause could be determined; however, the complaint may be due impaction on the device during the procedure.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6505488
• Report Number: 1719045-2017-10331
• Device Sequence Number: 16491619
• Product Code: HAW
• UDI-Device Identifier: 10705034719764
• UDI-Public: (01)10705034719764(10)6975892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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: 03.632.316
• Device Lot Number: 6975892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR