MAUDE Adverse Event Report: BIOMET UK LTD. G7 HARD BEARING INST RING SZ H; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number N/A

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Postal code: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

During the inspection of the kit in the (b)(4) warehouse, it has been detected that the ring is broken.Not patient involved.No surgery occurred.

Event Description

During the inspection of the kit in the zb spain warehouse, it has been detected that the ring is broken.Not patient involved.No surgery occurred.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Product has been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.During the inspection of the kit in the zb spain warehouse, it has been detected that the ring is broken.The instrument qty x 1 of item 110026857 / lot.019280 was returned for review.A visual examination confirms the g7 liner centering ring has a fracture and a piece missing.The part shows marks, dings and dents consistent with use in multiple surgeries over a period of time.The most likely cause from the investigation findings is that the centering ring was manufactured april 2017 and has most likely been used in many operations over several years and has sustained damage during use, this has caused a stress riser which has resulted in a fracture of the centering ring.Reference: reusable instrument lifespan manual.A review of the complaints database shows that we have received 5 reported events for damage for the same item number 110026857 prior to the reported event.Risk assessment: risk management file: alignment guides documents the estimated residual risk associated with the reported event.A) risk score severity 2 x occurrence 1 = 2 (negligible risk).B) occurrence rate assessment: september 2017 to september 2020; items sold the given period: 351668; occurrence ratio: 1:70333.C) complaint search criteria: item number 110026857 and complaint category: damaged; number identified: 5 (including initiating complaint).The severity of the reported event and calculated occurrence for similar complaints are in line with the risk file.The overall score is 2 (negligible risk).Corrective action, preventive action, and/or field action: item 110026857 & lot.No.019280 have not been involved in any previous field actions.No corrective/preventive actions are deemed necessary at this time.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: G7 HARD BEARING INST RING SZ H
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10634756
• MDR Text Key: 209980398
• Report Number: 3002806535-2020-00443
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 05019279998234
• UDI-Public: 05019279998234
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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 Model Number: N/A
• Device Catalogue Number: 110026857
• Device Lot Number: 019280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1