MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 32MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.201.032
Medical Device Problem Codes	Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 during a revision of an anterior lumbar fusion procedure on (b)(6) 2019, the surgeon attempted to remove the titanium cancellous locking screw from an unknown antegra plate.However, the screw was discovered to have a cold-welded and the inside of the screw head was stripped out.There was no surgical delay reported however the procedure was not successfully completed.Patient status is unknown.This complaint involves two (2) devices.This complaint is for one (1) 6.0 mm ti cancellous locking screw w/stardrive recess 32 mm.This report is 1 of 2 for (b)(4).
Event or Problem Description
It was further reported that the original screws placed on the left side was too long and was causing the patient issues.The left screw was removed and replaced with a shorter screw.The surgeon decided to remove the right side screw as well and was unable to remove due to the screw being cold welded.The implants were not removed and left in the patient.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 32MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9227316
• Report Number: 2939274-2019-61727
• Device Sequence Number: 1611399
• Product Code: KWQ
• UDI-Device Identifier: 10705034733883
• UDI-Public: (01)10705034733883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 04.201.032
• Device Catalogue Number: 04.201.032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR