MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 SPH CUTTER MED; BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Post code: (b)(6).Occupation: theatre manager.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the medium reamer for the oxford sheared at the connection to the chuck.A different set was opened and used with no problem.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.

Event Description

It was reported that the medium reamer for the oxford sheared at the connection to the chuck.A different set was opened and used with no problem.No delay of the procedure was reported.No impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred (b)(6).Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.An oxford spherical cutter was returned due to fracture after a maximum time in use of 9 years and 1 month.The cutter was returned assembled, with the fragment of the shaft assembly that the standard drill attaches to stuck to the rest of the shaft assembly, albeit with a gap.The instrument appears to be in overall good condition otherwise.The fracture surfaces on the received components suggest that the fracture occurred suddenly, as opposed to fracture due to fatigue.The relevant manufacturing history records (mhrs) for the oxford spherical cutter confirm that the hardness of the centre shaft assembly was in accordance with its specification.The manufacturing history records (mhrs) 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.A review of the complaint database over the last 3 years has found 2 similar complaints reported with item 32-420330.No similar complaints were found for the combination, item 32-420330 and lot zb090122.No corrective actions have been taken at this time since no design or manufacturing issues have been identified.The available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the fracture of the oxford spherical cutter with the information available.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.Failure analysis report concludes: an oxford spherical cutter was returned due to fracture after being used once in a maximum period of 9 years and 1 month.The fracture surface on the received component suggests that the fracture occurred suddenly, as opposed to fracture due to fatigue.The reported event did not cause a significant delay to the surgery or any other complication.The ultimate reason for the fracture of the oxford spherical cutter cannot be determined with the information available at the time of writing this report.The reported event states instrument fracture.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the rmr.The reported event is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.

• Brand Name: OXF UNI PH3 SPH CUTTER MED
• Type of Device: BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9863334
• MDR Text Key: 199871259
• Report Number: 3002806535-2020-00164
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2020
• 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: 32-420330
• Device Lot Number: ZB090122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1