MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9.0MM TI USS VARIABLE AXIS SCREW 50MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	499.375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight unknown.Additional product codes: mni, mnh, kwp, kwq.Device broke intra-operatively and was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported during a revision surgery that the removal of s1 screws that two implant holders broke.Additionally, while replacing the right s1 screw, two universal spine system-variable angle screws (uss-vas) broke - (the locking ring on the screw became dislodged and would not work).A third implant holder broke during final tightening, and a tip of the holder broke off into the left s1 screw and was not retrievable.It remained in the patient.While inspecting the uss-vas screwdrivers, it was discovered that the tips of the drivers were twisted.Replacements were requested.The revision surgery was captured as a postoperative event on a related product complaint (b)(4).Concomitant devices reported: unknown uss screws (part unknown, lot unknown, quantity 3).This is report 4 of 7 for (b)(4).

• Brand Name: 9.0MM TI USS VARIABLE AXIS SCREW 50MM THREAD LENGTH
• 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: 7429731
• Report Number: 2939274-2018-51667
• Device Sequence Number: 13882808
• Product Code: NKB
• UDI-Device Identifier: 10705034793887
• UDI-Public: (01)10705034793887
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• 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
• Report Date (Section B): 03/20/2018

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: 499.375
• Device Catalogue Number: 499.375
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR