MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 03/24/2021

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.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that whilst implanting an oxford cementless tibia, a part of the cementless tibial impactor broke off and was left in the wound.It was noticed and removed by the surgeon at the time of surgery but the potential was there for it to have remained in the wound inadvertently.No delay of the surgery.

Manufacturer Narrative

(b)(4).This report is to correct data.In error, it was previously reported that a review of the complaint database over the last 3 years has found no similar complaints for the item 32-422097.A review of the complaint database over the last 3 years has found 26 complaints reported with the item 32-422097 (including initiating complaint).As previously reported, an investigation evaluation and health hazard evaluation have previously been raised to address this issue.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of this complaint could not be determined with the information provided to date.Therefore, a line relating to a specific hazard could not be selected for assessment.Between 24 march 2018 to 24 march 2021: number of similar incidents identified: 26.Occurrence rate assessment for item 32-4220977 24 march 2018 to date of notification, 24 march 2021: (b)(4) units were sold.Therefore, the calculated occurrence (b)(4).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 risk management report.If further information regarding the root cause of the reported event are provided risk should be re-assessed.

Event Description

It was reported that whilst implanting an oxford cementless tibia, a part of the cementless tibial impactor broke off and was left in the wound.It was noticed and removed by the surgeon at the time of surgery but the potential was there for it to have remained in the wound inadvertently.No delay of the surgery.

Event Description

It was reported that whilst implanting an oxford cementless tibia, a part of the cementless tibial impactor broke off and was left in the wound.It was noticed and removed by the surgeon at the time of surgery but the potential was there for it to have remained in the wound inadvertently.No delay of the surgery.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.Investigation evaluation and health hazard evaluation have previously been raised to address this issue.A review of the manufacturing history records could not be performed as the lot number is unknown.A review of the complaint database over the last 3 years has found no similar complaints for the item 32-422097.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product has been returned for evaluation.As a result the lot number, zb151102 has now been identified.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that whilst implanting an oxford cementless tibia, a part of the cementless tibial impactor broke off and was left in the wound.It was noticed and removed by the surgeon at the time of surgery but the potential was there for it to have remained in the wound inadvertently.No delay of the surgery.

Manufacturer Narrative

Cmp-(b)(4).This final follow-up report is being submitted to relay additional information.Product has been returned for evaluation.A visual check of the returned product oxford cementless implant inserter (item 32-422097, lot.Zb151102) confirms that the hook has fractured off, there is evidence of wear and damage on all the surfaces, this suggests that this instrument has been used for many procedures since it was manufactured in 2016.The most likely cause is too much force being applied to the oxford cementless implant inserter during insertion of the tibial component or as there is evidence of wear and damage on all the surfaces, this suggests that this instrument has been used for many procedures since it was manufactured in 2016, therefore for this event the most likely root cause of the fracture to the impactor hook is wear and tear, ref.Reusable instrument lifespan manual 1219.4-glbl-en-issue date 2021-04-08, the product was most likely conforming to specification when distributed.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.A visual inspection of this device shows this event does not differ from previous reported events for the oxford cementless implant inserter as a result there is no change to the severity or occurrence for this event with the reported event is still considered to be within the severity of the risk management file.

Event Description

It was reported that whilst implanting an oxford cementless tibia, a part of the cementless tibial impactor broke off and was left in the wound.It was noticed and removed by the surgeon at the time of surgery but the potential was there for it to have remained in the wound inadvertently.No delay of the surgery.

• Brand Name: OXF CMNTLS IMPLANT INSERT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11655377
• MDR Text Key: 245125726
• Report Number: 3002806535-2021-00119
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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: 32-422097
• Device Lot Number: ZB151102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1