MAUDE Adverse Event Report: ORTHO DEVELOPMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 201-2107

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

Patient Problem Hip Fracture (2349)

Event Date 08/03/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a patient underwent hip arthroplasty to repair a femoral neck fracture.During broaching, the patient's bone cracked.The surgeon changed the stem size and used wire to repair the crack.According to the surgeon, the crack is attributed to the patient's fragile bone quality.

• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 7887653
• MDR Text Key: 120694068
• Report Number: 1722511-2018-00031
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-2107
• Device Lot Number: 20266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1