MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 8H/LT 194MM-STERIL; PLATE, FIXATION, BONE

Model Number	02.104.028S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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
Event occurred in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.Part number: 02.104.028s.Lot number: 6855283.Part manufacture date: 02-feb-2012.Part expiration date: 01-dec-2020.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The devices history record show this lot of 3.5mm lcp extra- articlr distal humerus pl 8h/lt 194mm-sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this raw material 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.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Photo investigation: the complaint device was not returned for investigation.A photo investigation was performed on the x-ray.The 3.5mm lcp distal humerus plate was removed following non-union of the fractured bone after a year of implantation.The complaint condition was not due to the plate and hence it will not be confirmed.A definitive root cause cannot be determined from the available information for this issue.A manufacturing record evaluation did not reveal any non-conformance that could have contributed to this issue.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.Conclusion: the complaint condition cannot be confirmed based on the images during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 patient underwent an orif (open reduction internal fixation) due to a nonunion fracture of the humerus.The original surgery performed approximately one (1) year ago for a gunshot wound.The hardware was mostly removed except for one (1) intact screw and one broken unknown 3.5 cortex screw tip that was retained.Bone grafting was performed and a new plate and screw construct was applied.This report involves one (1) 3.5mm lcp extra-articlr distal humerus pl 8h/lt 194mm-steril.This is report 1 of 11 for (b)(4).

• Brand Name: 3.5MM LCP EXTRA-ARTICLR DISTAL HUMERUS PL 8H/LT 194MM-STERIL
• 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: 12256601
• Report Number: 2939274-2021-04415
• Device Sequence Number: 2840712
• Product Code: HRS
• UDI-Device Identifier: 10886982029157
• UDI-Public: 10886982029157
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/02/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 02.104.028S
• Device Catalogue Number: 02.104.028S
• Device Lot Number: 6855283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Weight: 113