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

Catalog Number	803-15-002
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - item broke during surgery.A total of three broken within a week time frame between three different cases.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as heavy force being applied to the instruments during routine use.The possible time in service for impactor is 1 year and 5 months to 1 year and 10 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended, without delay.The instruments were inspected prior to use and were deemed acceptable for use based on their appearance.The agent was present during surgery and was able to source a suitable replacement device.The devices were returned to manufacturer and made available at djo surgical for examination.A review of the instruments' device history records (dhr) revealed the instruments, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows no prior complaints filed against the instruments' production lots that report a similar failure.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is heavy force being applied to the instruments during routine use.The incident instruments were from design revisions 01 and b, when the size of the material connection between impaction plate and main body was smaller.Revision c and onward design revisions are manufactured with a wider radius in the region of the instrument that connects the impaction plate to the main body, making the instruments more resistant to breakage and less likely to encounter this failure.There is low risk to the patient for this failure, so there's no need for removal of any design revision of this instrument from the field due to this issue.Therefore, no containment of inventory is required.Rma examination: the reported instruments were returned to djo for examination.All three devices have broken in the same way: the impaction plate has broken away from the main body.Each device's main body and impaction plate appear to fit together cleanly at the break line, there seems to be no material lost or left inside the patients.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: OFFSET 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12759034
• Report Number: 1644408-2021-01229
• Device Sequence Number: 6025965
• Product Code: HWA
• UDI-Device Identifier: 00190446286479
• UDI-Public: (01)00190446286479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/02/2021

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: 803-15-002
• Device Lot Number: 275689L01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female