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

Model Number	S-201106
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
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
Patient presented with arthritis of the glenohumeral joint, it was decided to initiate surgery for a reverse total shoulder replacement.During surgery, the baseplate was implanted and the short 4 barrel drill guide was placed onto the baseplate during insertion of that instrument (8-201106), a portion of central screw of the drill guide broke off in the baseplate.After several attempts to remove the screw and the baseplate (about 25-30 minutes) it was determined to rely on the morse tapers on the glenosphere and forgo the retaining screw.
Additional Manufacturer Narrative
See h4, h6, h10 and h11.Complaint has been evaluated and is similar to report number 1644408-2022-01145; s-201106, s303-broke/cracked/damaged, instrument failure.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 23763846
• Report Number: 1644408-2025-01895
• Device Sequence Number: 10083774
• Product Code: FZX
• UDI-Device Identifier: 00190446266068
• UDI-Public: 00190446266068
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: S-201106
• Device Lot Number: 111-11-111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male