MAUDE Adverse Event Report: BIOMET UK LTD. OXF KNEE PH3 I/M ROD RMVL HK L HK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being 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 a partial left knee replacement procedure, the surgeon was using the t-handle to remove intramedullar rod from the patient's femur when the little hook broke.All pieces have been retrieved from the patient.
Event or Problem Description
It was reported that during a partial left knee replacement procedure, the surgeon was using the t-handle to remove intramedullary rod from the patient's femur when the little hook broke.All pieces have been retrieved from the patient.
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.The reported event states that the pin fractured during the procedure and fell on the floor, no part fell in the patient.No patient harm or delay to procedure was reported and all fractured segments were retrieved.The surgeon was not using extra strength than usual.Visual inspection confirmed the reported event.The product was in the field for approximately 2 years and 9 months.The i/m rod removal tool exhibits signs of wear and tear around the location where the pins are attached to the shaft (scratches, nicks, dents) consistent with device usage.The large pin has fractured at the point where silver solder is applied to the shaft.The root cause of the pin fracturing from the shaft cannot be fully determined, the most likely cause is that the i/m rod removal tool pins have received excessive force over time.It is not possible to determine the number of procedures this instrument has been in use over the 2 years and 9 months it has been in the field.The dhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.All the lot ((b)(4) units) was accepted at the time of manufacturing.A review of the complaint database has found no similar complaints reported with this item / lot combination.A review of the complaints database for 3 years prior to the notification date has found 4 similar reported events, excluding this reported event, for item number (b)(4).(b)(4) concluded the root cause to be wear and tear, (b)(4), product not returned for evaluation, (b)(4), investigation ongoing and (b)(4), product not yet received for evaluation.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF KNEE PH3 I/M ROD RMVL HK L HK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8686367
• Report Number: 3002806535-2019-00496
• Device Sequence Number: 16772011
• Product Code: LXH
• UDI-Device Identifier: 05019279469246
• UDI-Public: 05019279469246
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 32-401111
• Device Lot Number: ZB170701
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 04/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention