MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROSTEP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 57S1MI07

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the elevator broke inside the bone during use.The broken portion was retrieved however another incision was made to remove the bone.

Manufacturer Narrative

Visual examination of the returned device confirms the tip has fractured off.The tip was not returned.

• Brand Name: PROSTEP
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington, tn
• MDR Report Key: 10174656
• MDR Text Key: 195759025
• Report Number: 1043534-2020-00122
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57S1MI07
• Device Lot Number: 1911554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR