MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION GUIDE

Model Number	323.050
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.Investigation summary: 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 history lot: lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.Device history batch: null.Device history review: null.
Event or Problem Description
It was reported that on (b)(6) 2021, a patient had and orif of a proximal humerus fracture and the surgeon left the insertion guide (323.050) attached to the plate and closed the patient.The insertion guide was still attached until follow up on (b)(6) 2021.There was no patient consequence reported.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) insertion guide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: INSERTION GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12863061
• Report Number: 2939274-2021-06799
• Device Sequence Number: 19176796
• Product Code: FZX
• UDI-Device Identifier: 10886982190697
• UDI-Public: (01)10886982190697
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 323.050
• Device Catalogue Number: 323.050
• Device Lot Number: 03-13321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: LCP PROXIMAL HUMERUS; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown