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

Catalog Number	S-201106
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
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 - due to the surgeon applied too much force and the screw broke off.The broken piece to the screw was left in the baseplate to prevent further complications.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as broken screw.The healthcare professional indicated that this event occurred during surgery, near the patient.The surgery was completed as intended, with a forty-minute 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 not returned to manufacturer and not made available for evaluation by registered medical assistant (rma) djo surgical.A review of s-201106 device history record (dhr) cannot be determined in the case that there is not a lot number to research.Complaint database review showed 5 previous complaints but there were no indications that this instrument has a design or material deficiency.Those are 5 - broke/cracked/damaged.The root cause of this complaint is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.This event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported device will not be returned to djo surgical for evaluation, as noted on the product feedback form.If at a later time the device is returned, an amendment will be opened.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this instrument failure was reported as broken screw.The healthcare professional indicated that this event occurred during surgery, near the patient.The surgery was completed as intended, with a forty-minute 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 not returned to the manufacturer and not made available at djo surgical for evaluation.A review of s-201106 device history record (dhr) cannot be determined in the case that there is not a lot number to research.Complaint database review showed 5 previous complaints but there were no indications that this instrument has a design or material deficiency.Those are 5 - broke/cracked/damaged.The root cause of this complaint is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.This event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported device will not be returned to djo surgical for evaluation, as noted on the product feedback form.If at a later time the device is returned, an amendment will be opened.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: 15403284
• Report Number: 1644408-2022-01145
• Device Sequence Number: 6124076
• 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): 11/07/2022

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 Catalogue Number: S-201106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/04/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71 YR
• Patient Sex: Female