MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP POSITIONER; POSITIONER, FMP ACET

Catalog Number 803-05-137

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure : while reamer with the handle broke, used a 2nd reamer it also broke while using the cup inserting threads broke off while inserting the cup some threads were left inside the cup in the patient.

Manufacturer Narrative

Manufacturer narrative: the reason for this instrument failure was reported as reamer with the broken handle.The possible time in service of the main contributor of this complaint is 1 year and 7 months from manufactured 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 no 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 records (dhr) revealed the instrument, 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 fifty-seven prior complaints filed against the instruments' item number that reports a similar failure.Those are 1 - functional, 4 - threads damaged/galled and 52 - broke/cracked/damaged.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.Product is being phased out and will be replaced with 803-05-337 straight acetabular impactor hip fmp.There are no indications that this instrument has a systemic 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 examination shows that the threaded tip of the positioner, fmp acet has broken off, confirming the complaint.The handle, acetabular reamer fmp is not manufactured by djo and will be sent to viant for investigation.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FMP POSITIONER
• Type of Device: POSITIONER, FMP ACET
• 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: 12699271
• MDR Text Key: 281133797
• Report Number: 1644408-2021-01143
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912104159
• UDI-Public: (01)00888912104159
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 803-05-137
• Device Lot Number: 312145L02
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 803-05-137 LOT UNKNOWN; 803-05-198 LOT 3304378; 803-05-198 LOT V75759001
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male