MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL PRIME STRAIGHT TORX SCREWDRIVER LONG; HIP INSTRUMENT

Model Number	P3SDTOSL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, while implanting cup, screw became stuck.Physician tried to tighten screw, and the tip of the driver broke off into the head of the screw.It was unable to be removed and is still implanted in the patient.Kit number: spthkit3 (2 pan).

• Brand Name: PROCOTYL PRIME STRAIGHT TORX SCREWDRIVER LONG
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11146471
• Report Number: 3010536692-2021-00010
• Device Sequence Number: 14354248
• Product Code: HWE
• UDI-Device Identifier: M684P3SDTOSL1
• UDI-Public: M684P3SDTOSL1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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?: No
• Operator of Device: Other
• Device Model Number: P3SDTOSL
• Device Catalogue Number: P3SDTOSL
• Device Lot Number: US101012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR