MAUDE Adverse Event Report: BIOMET UK LTD. G7 HARD BEARING INST RING SZ C; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Report source, foreign - event occurred in (b)(6).We have been informed by the customer that the product will not be returned to zimmer biomet for investigation.Associated product: medical product: g7 dual mobility liner 38mm c, catalog #: 110024461, lot #:638880.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that during impaction the inserter ring broke in two.Attempts have been made and no further information has been provided at this time.

Event Description

It was reported that during impaction the inserter ring broke in two.A second liner was impacted successfully and the surgery continued.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 4 complaints reported with the item (b)(4) (including initiating complaint).The image of the fractured inserter ring captured in the photograph supplied by the customer ((b)(4) photos) shows clear signs of surface damage on the top face of the ring which can be attributed to expected wear and tear over time, but no definitive information has been provided that could identify the root cause.As the lot number has not been supplied by the customer it was not possible to calculate the time spent in the field.The control of the kit components are covered on the visual inspection instructions in (b)(4) reusable instrument lifespan manual: inspection/function testing while loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions below.1.Instruments should be inspected for completeness and function.2.Inspection includes inspecting for all forms of wear outlined in this manual.3.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.4.If the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information, if any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned.

• Brand Name: G7 HARD BEARING INST RING SZ C
• 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: 11870171
• MDR Text Key: 252167181
• Report Number: 3002806535-2021-00222
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 110026852
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 67 YR