MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE -3; CER BIOLOXD OPT TYPE 1 TPR SLV

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested 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
During the surgery, when the product is ready to be implanted, the package is opened and the inside is empty.The package is in good condition.There is no product inside.The customer requested to return the empty package.
Event or Problem Description
During the surgery, when the product is ready to be implanted, the package is opened and the inside is empty.The package is in good condition.There is no product inside.The customer requested to return the empty package.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: it was reported that during surgery the outer packaging (pvp) was opened and the product was missing.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.No device has been returned.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Furthermore, the applicable work instruction valid at the time of manufacturing clearly describes how the (option sleeve) must be packaged.Furthermore, the history review showed that there is no other complaint for the same lot number and no other similar incident has been reported within the timeframe of one year.Therefore, it is highly unlikely that this reported event is a systematic issue.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.Item not returned.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -3
• Common Device Name: CER BIOLOXD OPT TYPE 1 TPR SLV
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12023579
• Report Number: 3002806535-2021-00266
• Device Sequence Number: 14588578
• Product Code: OQG
• UDI-Device Identifier: 00887868271472
• UDI-Public: 00887868271472
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 650-1065
• Device Lot Number: 3035286
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 72