MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI CANN MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.606.650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: mnh, mni, kwq, kwp.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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 that during a posterior spinal fusion procedure using the minimally invasive spine (mis) fashion on (b)(6) 2018, while attempting to place the locking cap on a screw on one side of the construct, surgeon applied too much force on the screw, causing the screw head to dissociate from the screw shaft.Surgeon opted to remove the screw entirely and replace with another screw.Patient was not affected and no delay was experienced.Concomitant device reported: screwdriver (part number unknown, lot number unknown, quantity 1) this report is for one (1) 6.0mm cannulated matrix polyaxial screw 50mm thread length.This is report 1 of 1 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found to be a duplicate.
Additional Manufacturer Narrative
The initial complaint was reviewed and found to be a duplicate.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: 6.0MM TI CANN MATRIX POLYAXIAL 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: 7385392
• Report Number: 2939274-2018-51359
• Device Sequence Number: 1221005
• Product Code: NKB
• UDI-Device Identifier: 10705034735559
• UDI-Public: (01)10705034735559(10)H457057
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 04.606.650
• Device Catalogue Number: 04.606.650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1