MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CASES/TRAYS/MODULES; TRAY,SURGICAL INSTRUMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - cases/trays/modules/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 Description

It was reported that during an orif vs crif of the hand procedure on august 24, 2020, the unknown tray was delivered late.The tray was supposed to be delivered on sunday morning, a day before the scheduled case.It was mentioned that the patient was already under anesthesia when the tray arrived.The surgeon ended up pinning the metacarpals.The procedure was successfully completed with an unspecified duration of surgical delay reported.Patient status was unknown.This complaint involves one (1) device.This report is for (1) unk - cases/trays/modules.This is report 1 of 1 (b)(4).

• Brand Name: UNK - CASES/TRAYS/MODULES
• Type of Device: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10554671
• MDR Text Key: 207742040
• Report Number: 2939274-2020-04212
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention