MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SPECIAL SURGICAL INSTRUMENT; SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE

Catalog Number	S-201106
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Primary surgery complaint - a health professional reported that the central screw in the 4-hole drill guide broke inside the baseplate making it impossible to drill or introduce the retaining screw to secure the glenoid head.The surgery was completed with another device after a 10 minute delay.There was no patient impact.

• Brand Name: RSP SPECIAL SURGICAL INSTRUMENT
• Common Device Name: SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 12476392
• Report Number: 1644408-2021-00989
• Device Sequence Number: 3687203
• Product Code: FZX
• UDI-Device Identifier: 00190446266068
• UDI-Public: (01)00190446266068
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S-201106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1