MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 38MM FOR TI HUMERAL NAILS; NAIL, FIXATION, BONE

Model Number	462.638
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient staying under anesthesia while devices were retrieved.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 or Problem 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.(b)(4).

• Brand Name: TI SPIRAL BLADE 38MM FOR TI HUMERAL NAILS
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9079132
• Report Number: 2939274-2019-60655
• Device Sequence Number: 11381470
• Product Code: JDS
• UDI-Device Identifier: 10886982231895
• UDI-Public: (01)10886982231895
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K992348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 462.638
• Device Catalogue Number: 462.638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention