MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; DRILL GUIDE, TWO PIECE, RSP

Catalog Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - during reverse with surgeon the guide for the peripheral screws broke.The central screw broke inside the baseplate below the surface.Had to pull baseplate, wasted implant.
Additional Manufacturer Narrative
Manufacturer narrative: see d.4., d.9., e.1., e.2., e.3., g.1.& h.3.Corrected data: the reason for this instrument failure was reported as guide to the peripheral screw broke and the central screw broke inside the baseplate.The possible time in service of the main contributor of this complaint is 9 years and 5 months from manufactured date.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based onits appearance.The device was disposed of at hospital 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 was no non-conforming material report (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows twenty-six prior complaints filed against the instruments' item number that reports a similar failure.Those are 26 - broke/cracked/damaged.No prior complaints report past instances of these instruments being affected by this failure.Review also shows no prior complaints against the instruments' lot number.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.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported instrument was returned to djo however, the complaint cannot be confirmed because the parts pertaining to the event were not returned with the drill guide, two piece, rsp.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: DRILL GUIDE, TWO PIECE, RSP
• 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 11225162
• Report Number: 1644408-2021-00007
• Device Sequence Number: 715491
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/06/2021

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: 804-03-048
• Device Lot Number: 59835L02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2011
• 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: 65 YR
• Patient Sex: Male