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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the inspection of the kit in the zimmer biomet spain warehouse, it has been detected that the piece is broken.Not patient involved.No surgery occurred.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Products have 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 piece is broken.The instrument qty x 1 of item 110026857 / lot.411500 was returned for review.A visual examination confirms the g7 liner centering ring has a fracture and a piece missing.There is also impact damage to the edge of the centering ring.The most likely cause from the investigation findings is that the centering ring was manufactured february 2015 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.A review of the complaints database shows that we have received 3 reported events for instrument: fracture for the same item number 110026857 prior to the reported event.Risk assessment: a.Severity assessment: the severity associated with the above line is 2.This gives a severity score of 2, potential for extended surgery time.The actual severity score is in line with the risk file.B.Occurrence rate assessment: 27 may 2017 to 24 september 2020: (b)(4) items sold the given period.3 similar complaints identified.The risk management file documents the estimated residual risk associated with the reported event.The severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is low risk.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.
Event or Problem Description
It was reported that during the inspection of the kit in the zimmer biomet spain warehouse, it has been detected that the piece is broken.Not patient involved.No surgery occurred.

• Brand Name: G7 HARD BEARING INST RING SZ H
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10354664
• Report Number: 3002806535-2020-00345
• Device Sequence Number: 971636
• Product Code: LPH
• UDI-Device Identifier: 05019279998234
• UDI-Public: 05019279998234
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110026857
• Device Lot Number: 411500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1