MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR POROUS KNEE; DJO EMPOWR KNEETM PUNCH HANDLE

Catalog Number	801-05-040
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Instrumental failure the tibial punch inserter broke off inside the patient.All pieces were retrieved.Small delay in cases.
Additional Manufacturer Narrative
The reason for this instrumental failure was reported as broken tibial punch inserter.The possible time in service of the main contributor of the complaint is 1 year and 9 months from the manufacturer date.The healthcare professional indicated 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 a five-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) (b)(4).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 non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review shows four prior complaints filed against the instrument item number that reports a similar failure.Review shows no prior complaints against the instruments lot number that report a similar failure.Those are 4 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.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported instrument was returned to (b)(4) and after further examination, the tip of the (b)(4) empowr kneetm punch handle 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
The reason for this instrumental failure was reported as broken tibial punch inserter.The possible time in service of the main contributor of the complaint is 1 year and 9 months from the manufacturer date.The healthcare professional indicated 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 a five-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The devices were 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 non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review shows four prior complaints filed against the instrument item number that reports a similar failure.Review shows no prior complaints against the instruments lot number that report a similar failure.Those are 4 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.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported instrument was returned to djo and after further examination, the tip of the djo empowr kneetm punch handle is broken off.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrumental failure the tibial punch inserter broke off inside the patient.All pieces were retrieved.Small delay in cases.

• Brand Name: EMPOWR POROUS KNEE
• Common Device Name: DJO EMPOWR KNEETM PUNCH HANDLE
• 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: 13047029
• Report Number: 1644408-2021-01436
• Device Sequence Number: 14481042
• Product Code: MBH
• UDI-Device Identifier: 00190446238881
• UDI-Public: (01)00190446238881
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 801-05-040
• Device Lot Number: 318871L10C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 152 KG