MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.617.814
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Additional product code: kwq.(b)(4) - lot number unknown.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales consultant.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 or Problem Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6) 2018, three (3) separate 3.0mm cervical spine locking screws chipped during the torqueing stage.No fragments were generated.The screws were replaced with new screws, surgery was completed with no further issues.This report is for one (1) 3.0mm cervical spine locking screw.This is report 3 of 3 for (b)(4).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7329132
• Report Number: 2939274-2018-50992
• Device Sequence Number: 109555
• Product Code: OVE
• UDI-Device Identifier: 10705034742274
• UDI-Public: (01)10705034742274(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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 Model Number: 04.617.814
• Device Catalogue Number: 04.617.814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1