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 Codes	Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of postoperative non-union development is unknown.Additional device product code: jds complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 osteotomy of the olecranon on (b)(6) 2018 to fix the humerus.The osteotomy was repaired with an olecranon plate, 2 cortex screws, and 4 variable angle (va) locking screws.On (b)(6) 2018 the patient had a removal of variable angle locking compression plate due to non-union.It was noted that the proximal olecranon did not heal and the piece of bone came out of the screw plate construct, and patient also experienced malunion and decreased range of motion.There was no other medical intervention required.There was no surgical delay reported.The procedure was successfully completed.The patients' proximal olecranon was removed and the patient outcome was stable.This is report 3 of 7 for complaint (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: 7671430
• Report Number: 2939274-2018-52752
• Device Sequence Number: 906513
• 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 Implanted Year: 2018
• 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): 06/12/2018

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: 06/12/2018
• Initial Report FDA Received Date: 07/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 78