MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM-STER; PLATE, FIXATION, BONE

Model Number	02.107.002S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of birth and patient weight not available for reporting.Date when loss of fixation occurred is unknown.Additional product code: hwc.Devices were not explanted.Devices are not available for return.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.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 patient underwent original procedure for open reduction of internal fixation on (b)(6) 2017.Post operatively, a tip of bone / olecranon was separated from the plate.Revision procedure was performed on (b)(6) 2018.No hardware was removed.Surgeon repaired tip of olecranon which was separated from plate with suture.The plate and ten (10) screws were still implanted in patient and were intact.Reporter confirmed that there was no malfunction associated with plate and then (10) screws.There was no delay in procedure and was completed successfully without any complications.Patient outcome was good.Concomitant devices: screws (part# unknown, lot# unknown, qty 10).This is report 1 of 1 (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7240851
• Report Number: 2939274-2018-50486
• Device Sequence Number: 13712173
• Product Code: HRS
• UDI-Device Identifier: 10886982029232
• UDI-Public: (01)10886982029232(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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: 02.107.002S
• Device Catalogue Number: 02.107.002S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR