MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CURVED NARROW LCP PLATE 10 HOLES; PLATE, FIXATION, BONE

Model Number	02.161.240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # 02.161.240.Synthes lot # h850466.Supplier lot # n/a.Release to warehouse date: 28 mar 2019.Manufacturing location: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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, patient underwent the hardware removal procedure due to leg pain. surgeon removed (5) 4.5 cortex screws and a plate from patient¿s right femur.The procedure was successfully completed without any surgical delay.This report is for (1) 4.5mm curved narrow lcp plate 10 holes.This is report 1 of 6 for complaint (b)(4).

• Brand Name: 4.5MM CURVED NARROW LCP PLATE 10 HOLES
• 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: 12627837
• Report Number: 2939274-2021-06100
• Device Sequence Number: 11829889
• Product Code: HRS
• UDI-Device Identifier: 10886982047052
• UDI-Public: (01)10886982047052
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K092609
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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 Model Number: 02.161.240
• Device Catalogue Number: 02.161.240
• Device Lot Number: H850466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Weight: 20