MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL PRIME BALL & SOCKET TORX SCREWDRIVER LS; HIP INSTRUMENT

Model Number	P3SDTOSL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, tip of screwdriver broke off in use inside patient.Additional information received on 09/11/2020 from (b)(6) : confirmation that the tip instrument remained inside the patient.

• Brand Name: PROCOTYL PRIME BALL & SOCKET TORX SCREWDRIVER LS
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10602753
• Report Number: 3010536692-2020-00631
• Device Sequence Number: 2578253
• Product Code: HWE
• UDI-Device Identifier: M684P3SDTOSL1
• UDI-Public: M684P3SDTOSL1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: P3SDTOSL
• Device Catalogue Number: P3SDTOSL
• Device Lot Number: US101012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR