MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 8H/LT/169MM-STER; PLATE,FIXATION,BONE

Model Number	02.107.308S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device procode: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part: 02.107.308s, lot: h610834.Manufacturing location: (b)(4), manufacturing date: may 01, 2018, expiry date: mar 31, 2028.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record determined the raw material lot met all specifications with no issues documented that would contribute to this complaint condition.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.If additional information is made available, the investigation will be updated as applicable.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) 2019, the patient underwent hardware removal of one (1) olecranon plate, one (1) metaphyseal screw, five (5) cortex screws, and six (6) variable angle (va) locking screws.The patient had a malunion, wound not closing, infection, and nonunion of her left elbow olecranon plate.It is unknown if there was surgical delay.Procedure was successfully completed.Patient outcome was good.This report is for one (1) olecranon plate.This is report 1 of 4 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 8H/LT/169MM-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: 8650359
• Report Number: 2939274-2019-58363
• Device Sequence Number: 13974793
• Product Code: HRS
• UDI-Device Identifier: 10886982029393
• UDI-Public: (01)10886982029393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 02.107.308S
• Device Catalogue Number: 02.107.308S
• Device Lot Number: H610384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR