MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.018.225S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Part: 04.018.225s, lot: l795401, manufacturing site: (b)(4), release to warehouse date: may 3, 2018, expiry date: april 1, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.(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 or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of one (1) multiloc humeral nail, three (3) unknown 4.5mm multiloc screws, one (1) unknown 3.5mm locking screw and two (2) unknown 4.0mm locking screws.It is unknown what was the reason for the removal of the devices.The procedure was successfully completed but it is unknown if there was a surgical delay.Patient status is unknown.Concomitant devices reported: screws: trauma (part number unknown, lot unknown, quantity 3), screws: locking (part number unknown, lot unknown, quantity 3).This report involves one (1) 8.5mm ti multiloc humeral nail right/ cann/ 225mm-sterile.This is report 1 of 7 for (b)(4).

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10183646
• Report Number: 2939274-2020-02934
• Device Sequence Number: 16352533
• Product Code: HSB
• UDI-Device Identifier: 10886982089458
• UDI-Public: (01)10886982089458
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 04.018.225S
• Device Catalogue Number: 04.018.225S
• Device Lot Number: L795401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention