MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Model Number	71677100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent through a per-trochanteric fracture.The same was fixed with a trigen intertan interlocking screw lag screw 100mm/compression screw 95mm.Revision surgery was performed and it was noticed that the device mentioned was broken.The surgeon associates this fracture with continuous loading cycles and subsequent fatigue of the device.

• Brand Name: LAG/COMP SCREW KIT 100/95
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9914321
• Report Number: 1020279-2020-01115
• Device Sequence Number: 3423391
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (Y/N): N
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 71677100
• Device Catalogue Number: 71677100
• Device Lot Number: 19DM15815
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1