MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL SM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2019

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.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 foam in the sterile packaging stuck to the sterile lid.Subsequently, the hospital considered the implant to be non-sterile.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The products was returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that it was identified that the top foam has adhered to the tyvek lid.This event occurred during surgery.No further information has been provided.No harm was reported.The complaint has been confirmed following review of the returned packaging, which confirmed the foam has adhered to the tyvek lid.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified 11 similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The reported event is covered by inst 4.4.1.9 input output risk table ¿ sterile device packaging, revision 03.The severity of the reported event and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.The overall risk score is negligible.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states to check the packaging for damage before use.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The correct packaging materials and sealing methods have been used.The likely cause of the reported event is not enough clearance between the top foam and the tyvek lid during the heat sealing process.This causes unintended heat transfers between the top foam and the tyvek lid, resulting in adhesion.The indent in the top foam (which have been caused by compression from the device) further indicate that the space within the blister would have been limited.Issue evaluation (b)(4) has been raised to further investigate this issue.Health hazard evaluation (b)(4) has been raised to assess the risk of product which may exhibit the issue in the field.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that the foam in the sterile packaging stuck to the sterile lid.Subsequently, the hospital considered the implant to be non-sterile.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL SM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9574299
• MDR Text Key: 190334829
• Report Number: 3002806535-2020-00014
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 166941
• Device Lot Number: J6605411
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1