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

Model Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2022
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
Instrument failure - surgeon was attaching the two piece drill guide to the baseplate and was not able to because the tip of the screw broke off in the baseplate.When he was putting on the glenosphere he was unable to put in the set screw because of the metal piece.Everything finished with no issue.
Additional Manufacturer Narrative
The reason for this complaint was reported as accidental rough handling by surgical personnel.The possible time in service for baseplate is 2 years and 3 months from manufactured date.This event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review shows three prior complaints filed against the instruments item number that reports a similar failure.Those are 3 broke/cracked/damaged.However, the customer complaint history of the reported device showed no present trends or on-going issues that are needing review.The most likely root cause of this complaint was accidental rough handling by surgical personnel.It's possible that the surgeon applied excessive torque with a hex driver while assembling the drill guide's thumb screw into the rsp baseplate, thus subjecting it to more torque than recommended.Additionally, if the surgeon had aligned the thumb screw with the baseplate at an incorrect angle, this too could've caused cross-threading to occur, putting more strain on the drill guide's thumb screw.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo, however, the part number listed on the pc form does not match the rma that was returned to djo.After examining the special, shortened rsp baseplate drill_screw guide, the tip of the thumb screw is broken off.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Common Device Name: SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 14105064
• Report Number: 1644408-2022-00465
• Device Sequence Number: 4961263
• Product Code: FZX
• UDI-Device Identifier: 00190446266068
• UDI-Public: (01)00190446266068
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/27/2022

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 Model Number: 804-03-048
• Device Catalogue Number: S-201106
• Device Lot Number: 319012L04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 04/28/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/20/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female