MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL® PRIME FLEX DRILL BIT 4.0 X 20MM; HIP INSTRUMENT

Model Number	P3FDB420
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/14/2022
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, troubleshooting: 4.0 mm x 20 mm drill and the drill guide was used to make a screw hole for the placement of a prime cup fixation screw.During this procedure, a blood vessel was injured and bleeding was observed postoperatively.This was considered a technical error by the dr.Surgeon's finding: considered a technical error by the surgeon.Findings of the reporter and status of response: hp and the patient had a problem, and hp asked for a document showing the shape of the screw drill ?p3fdb420 prime flexible drill bit 4.0 x 20mm? (b)(4).

• Brand Name: PROCOTYL® PRIME FLEX DRILL BIT 4.0 X 20MM
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 16122660
• Report Number: 3010536692-2023-00005
• Device Sequence Number: 17752636
• Product Code: GFG
• UDI-Device Identifier: M684P3FDB4201
• UDI-Public: M684P3FDB4201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: P3FDB420
• Device Catalogue Number: P3FDB420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown