MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/26MM; SCREW, FIXATION, BONE

Model Number	02.118.526
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
Patient id: (b)(6).Patient weight is unknown.Additional product code: hrs.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 complaint number (b)(4).This is report 8 of 8 for (b)(4).
Event or Problem Description
It was further reported that plate and screws were removed successfully.
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.Date of report: this date was reported as 7/31/2018 in error.The correct date should have been 7/16/2018.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 METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/26MM
• 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: 7753815
• Report Number: 2939274-2018-53204
• Device Sequence Number: 1719860
• Product Code: HWC
• UDI-Device Identifier: 10886982039323
• UDI-Public: (01)10886982039323
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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,Followup
• 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: 02.118.526
• Device Catalogue Number: 02.118.526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention