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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This report is for tray, surgical instrument /unknown lot.Part and lot numbers are unknown; udi number is unknown.(b)(4).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 Description

It was reported on (b)(6) 2019, during an unknown procedure, it was found out that an unknown humeral nail set do not have an unknown caddy with an unknown blades, unknown 4.0 titanium screws and unknown end caps.Originally, the sales consultant gets the set and there¿s going to be a tote with implants for blades and screws and end caps.The sales consultant called the fsl and eventually discovered that there was supposed to be a caddy inside the set.The sales consultant then go and drive to another hospital and return with a tote for said implants.The procedure was successfully completed; however, the patient spent an extra 100 minutes under anesthesia.Also, the end cap available from the other hospital was not the correct size, so it protruded from the patient¿s humeral head.Re-operation is most likely.Procedure and patient outcome were unknown.This complaint involves thirty-eight (37) devices.This is report 8 for 8 (b)(4).Other devices was included with related incidents: (b)(4).

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.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

The fsls had two (2) kits with different set configurations.The set the consultant ordered was complete with no missing parts.The consultant must have ordered the wrong kit.

• 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
• MDR Report Key: 9082252
• MDR Text Key: 163302726
• Report Number: 2939274-2019-60674
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention