MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP OLECRANON PLATE 10 HOLES/LEFT/190MM; APPLIANCE,FIXATION,NAIL

Model Number	236.511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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 an unknown date, the patient returned to surgery for revision olecranon plate.The revision was due to fracture never properly being reduced in the previous surgery.All hardware was intact.There was no surgical delay reported.The procedure was successfully completed.Patient consequence revised orif of olecranon fracture.This (b)(4) captures 9 unknown screws and 1 plate, while (b)(4) captures three (3) out of twelve (12) unknown screws.This complaint involves ten (10) devices.This report is for one (1) 3.5mm lcp olecranon plate 10 holes/left/190mm.This report is 1 of 10 for (b)(4).

• Brand Name: 3.5MM LCP OLECRANON PLATE 10 HOLES/LEFT/190MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10134366
• Report Number: 2939274-2020-02716
• Device Sequence Number: 14249083
• Product Code: KTT
• UDI-Device Identifier: 10886982160836
• UDI-Public: (01)10886982160836
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 236.511
• Device Catalogue Number: 236.511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 57