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

Model Number N/A

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign event occurred in (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 tibia impactor broken off at the tip during surgery.Subsequently, a slight delay occurred while replacing the instrument.

Event Description

It was reported that a tibia impactor broken off at the tip during surgery.Subsequently, a slight delay occurred while replacing the instrument.

Manufacturer Narrative

(b)(4).Products have been returned to biomet uk ltd.For evaluation.Device history record (dhr) was reviewed and no discrepancies were found.A review of the complaints database has found 38 similar complaints for the item code 32-422097.Visual inspection confirmed the reported event.The posterior foot is fractured.The fractured part has been 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 inferior surface of the handle is free from significant dents.One of the replaceable blue plugs is missing.The risk assessment determined that the rate of occurrence, as currently specified in the applicable risk file, is acceptable.The risk assessment was re-assessed in the ie-11604 and meets the pre-defined risk requirements the risk covered by this specific line in the risk file remains within our defined acceptable risk limits, therefore, there is no increase in the risk of the event leading to minor exposure to anaesthesia.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" 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
• 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: 9278626
• MDR Text Key: 165218795
• Report Number: 3002806535-2019-00841
• 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: foreign,health professional
• 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: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB161003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1