MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 50MM; SCREW, FIXATION, BONE

Model Number	02.211.050
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Date of event is unknown.Additional product code: hrs.Not implanted or explanted, no patient involvement.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history record review could not be requested.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 that on (b)(6) 2018 a 2.7mm variable angle locking self-tapping screw was noted as bent.This was determined during a routine incoming inspection.This complaint does not involve a patient or a procedure.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Event or Problem Description
This report is for a 2.7mm variable angle (va) locking screw.
Additional Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation is in progress, 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.
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.Visual inspection shows that the implant is bent inward about 1/3 third of the way down from the proximal end.The balance of the device is in worn condition.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: outer diameter: ø 2.70 max; min of ø 2.10 +0/0.10 with the thread pitch 0.30 (x2) and a surface profile of 0.1 mm leads to a range of 2.50 ¿ 2.70 mm.Measured dimensions: outer diameter: 2.63 mm; conforming , device used: ca215p.A device history review could not be performed as the lot number is unknown.A review of the current design drawing was performed.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during usage or handling could have contributed to complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7920819
• Report Number: 2939274-2018-53998
• Device Sequence Number: 2305204
• Product Code: HWC
• UDI-Device Identifier: 10886982053763
• UDI-Public: (01)10886982053763
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 02.211.050
• Device Catalogue Number: 02.211.050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/24/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/16/2018; 10/25/2018
• Patient Sequence Number: 1