MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes mnh, mni, kwq, kwp.Occupation: initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.(b)(4).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 on (b)(6) 2019, during a posterior lumbar fusion revision surgery, a matrix screwdriver shaft stardrive broke in the matrix locking cap.The broken screwdriver tip was stuck in the locking cap.The screwdriver tip could not be removed, so the surgeon had to cut the rod to remove the screw.There was a forty-five to sixty (45-60) minute delay in the procedure.The procedure was successfully completed.This report is for one (1) ti matrix locking cap.This is report 2 of 2 for (b)(4).This (b)(4) captures the intra-op event which involves the matrix screwdriver shaft stardrive that broke in the matrix locking cap while (b)(4) captures the post-op event involving the adjacent level disease.

• Brand Name: TI MATRIX LOCKING CAP
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8394937
• Report Number: 2939274-2019-56837
• Device Sequence Number: 19564580
• Product Code: NKB
• UDI-Device Identifier: 10705034744964
• UDI-Public: (01)10705034744964
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 04.632.000
• Device Catalogue Number: 04.632.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention