MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 20MM; SCREW, FIXATION, BONE

Model Number	204.820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient weight is unknown.Date of event: unknown.Additional product code: jds.Implant date: unknown.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 that the patient underwent removal of variable angle locking compression plate (va-lcp) olecranon plate on (b)(6) 2018, due to pain.During removal of the plate, the screwdriver would not disengage from the screwdriver handle.Another screwdriver was used to successfully complete the procedure with a ten (10) minute delay.Patient outcome was not reported.This report will address the complaint about the va-lcp olecranon plate that was removed due to pain.The screwdriver blade and screwdriver handle have been captured under related (b)(4).This is report 3 of 8 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 20MM
• 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: 7753484
• Report Number: 2939274-2018-53199
• Device Sequence Number: 1337552
• Product Code: HWC
• UDI-Device Identifier: 10886982146281
• UDI-Public: (01)10886982146281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.820
• Device Catalogue Number: 204.820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention