MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MILLING BIT HXC-STERILE

Catalog Number	03.820.153S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.(b)(6).Patient weight not provided for reporting.Device is an instrument and malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Device history records review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was report that the patient had original surgery on (b)(6) 2018 for treatment of a spine cervical artificial disc replacement (pdc) implant at c5-c6 disc levels.Patient was implanted with one (1) level unknown pdc implant.Inter-operatively, it was reported that a milling bit hxc instrument tip broke during the procedure.After the surgeon had completed the superior keel cut, the milling bit was placed in the inferior keel port.The bit tip broke after milling was only about 80% complete.No harm was reported to the patient.The milling bit was removed by removing the guide and the keel cut was completed using a chisel.The case proceeded without issue.Surgery was completed successfully with no time delay.Patient is reported in stable condition.Reporter has no more information to report on this event.Concomitant device unknown artificial disc replacement pdc (item # unknown, lot # unknown, quantity 1 each).This report is for one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part number: 03.820.153s, synthes lot number: 7604638, supplier lot number: n/a, release to warehouse date: 22-may-2014, expiration date: 30-apr-2019, manufactured by (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Corrected data: common device name.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: MILLING BIT HXC-STERILE
• Common Device Name: BIT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7401680
• Report Number: 2939274-2018-51492
• Device Sequence Number: 1263969
• Product Code: GFG
• UDI-Device Identifier: 10705034731827
• UDI-Public: (01)10705034731827(17)190430(10)7604638
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 03.820.153S
• Device Lot Number: 7604638
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR