MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent initial left tibial implantation.A control x-ray displays a metallic part close to the polyethylene insert.Subsequently, the metallic part was removed with the control of the image intensifier.

Event Description

It was reported that a patient underwent initial left tibial implantation.A control x-ray displays a metallic part close to the polyethylene insert.Subsequently, a revision surgery was performed to remove the metallic part with the control of the image intensifier.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in france.D10:the product has been returned to zimmer biomet for investigation.Risk was re-assessed in the ie-11604 and meets the pre-defined risk requirements given in the risk file.Visual inspection confirmed the reported event.The posterior foot is fractured.The fractured part was not returned.The dents on the superior handle surface and the tarnish of the instrument¿s body indicate that the instrument has been used multiple times.The instrument was returned with both blue cushions attached.The inferior surface of the handle has minor dents, however, it is impossible to form the information given in the complaint to determine whether the damage occurred during operation, the instrument was misused, or reprocessing, the instrument was sterilised with other instruments in a basket.The memorandum from the development team attached in the hhe details possible misuse scenarios in which the posterior tab may be subjected to loading that could have caused the reported fracture.These scenarios are: 1)use of the inserter to fully impact the device, resulting in posterior tab becoming trapped between the bone and implant.2) use of excessive force when tightening the thumbwheel may lead to high anterior-posterior loading on the posterior tab.3)use of the inserter to remove a partially or fully seated implant, by impacting an internal surface in a direction up and away from the patient; 180deg.Opposite to the impaction required for the insertion¿ ¿¿ the instructions for reusable surgical instruments, doc.No.5401000246 version 2.3 (march 2009), warns that: ¿¿maintenance, inspection and functional testing: all instruments should be visually checked for damage and wear.Cutting edges should be free of nicks and present a continuous edge.¿¿ reusable instrument lifespan manual (219.3-glbl-en-rev0419) provides verbal and visual instruction on how to detect instrument fracture.Surgical technique 0338.2-emea-en contains the following instructions: ¿¿the knee is flexed fully and, using the toffee mallet, the component is then carefully impacted¿before it is fully seated, the introducer/impactor is removed by unscrewing the thumbwheel.¿¿ ¿¿final impaction of the tibial component is achieved with the toffee mallet and the standard impactor placed centrally over the knee¿¿ the mhr does not show any non-conformity, rejection or concession that could be related to the reported event.A review of the complaint database over the last 3 years has found 38 similar complaints for this item code 32-422097.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF CMNTLS IMPLANT INSERT IMPACTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9249232
• MDR Text Key: 164112760
• Report Number: 3002806535-2019-00832
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB151101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 86