MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP OLECRANON PL 2H/LT/90; PLATE, FIXATION, BONE

Model Number	02.107.302
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown date in 2021.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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) 2021, the surgeon performed an orif of the left olecranon six weeks ago using our depuy synthes 2 hole left valcp olecranon plate.The proximal fragment cut out of the plate and screw construct causing a non-union and one hundred percent displacement of the proximal fragment.The patient unlocked her brace, giving her too much range of motion and exercise too early, resulting in the treatment failure.The surgeon revised the olecranon on (b)(6) 2021 using our 4 hole valcp olecranon plate and osteocrete bone graft from another manufacturer.Her bone cut out away from the screws and pulled off the plate.The revision surgery was performed successfully.No patient consequence.This report is for one (1) 2.7/3.5 va-lcp olecranon pl 2h/lt/90.This is report 1 of 2 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the x-ray image.The image was reviewed, and the complaint condition is confirmed.The olecranon plate is clearly out of position.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety 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.

• Brand Name: 2.7/3.5 VA-LCP OLECRANON PL 2H/LT/90
• 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: 12555746
• Report Number: 2939274-2021-05821
• Device Sequence Number: 19063574
• Product Code: HRS
• UDI-Device Identifier: 10886982029331
• UDI-Public: (01)10886982029331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.107.302
• Device Catalogue Number: 02.107.302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR