MAUDE Adverse Event Report: ENCORE MEDICAL L.P. IMPACTOR; STRAIGHT ACET. IMPACTOR, EMPOWR

Model Number	940-02-60I
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the surgeon attempted to impact the cup into the patient.The cup would not dislodge/unscrew from the impactor.After several failed attempts to unscrew it the surgeon removed the cup and impactor and put in a new cup using a new impactor.After impaction of the second cup the second impactor would not unscrew from the second cup initially.After several attempts the surgeon removed the second cup and impactor from the patient.Once out of the patient, the surgeon was able to remove that cup, after several more attempts by using a screwdriver to leverage the impactor.He then wanted to use a third impactor to implant the second cup and did so successfully.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this instrument failure was reported as impaction of cup into the patient.The possible time in service for baseplate is 3 years and 8 days from manufactured date.The healthcare professional this event occurred during surgery, near the patient.There was a twenty minute delay in surgery but the surgery was completed as intended.The surgeon indicated there was no risk or adverse event.The device was inspected prior to use and found to be acceptable.The agent was present during surgery and was able to provide another suitable device.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the production of the instrument that is related to the reported issue.Complaint database review showed 1 previous complaint for the alleged issue but there were no indications that this instrument has a design or material deficiency.Those are - threads damaged/galled.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.It is likely the device was threaded incorrectly causing resistance with engagement.The damage on the empowr acet system cup indicates there was rough handling.There are no indications that the instrument has a 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 devices were returned to djo surgical for evaluation.There is damage on the 3/8-24 unf-2a thread of the straight acet.Impactor, empowr.However, both of the straight acet.Impactors were able to fully thread into the empowr acet system, cup, hemispherical, cluster hole, 60mm and sat flush.The empowr acet system, cup, hemispherical, cluster hole, 60mm has some damage within the interior.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: IMPACTOR
• Common Device Name: STRAIGHT ACET. IMPACTOR, EMPOWR
• 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: 15194712
• Report Number: 1644408-2022-00994
• Device Sequence Number: 12170688
• Product Code: HWA
• UDI-Device Identifier: 00190446289210
• UDI-Public: (01)00190446289210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• 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
• Report Date (Section B): 09/08/2022
• 2 Devices were Involved in the Event: 1 2

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: 940-02-60I
• Device Catalogue Number: 803-15-001
• Device Lot Number: 292586L02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 803-15-001 LOT 292586L02; 803-15-001 LOT 342078L15; 803-15-001 LOT 342078L15; 940-02-60I LOT 804Z1022
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male