MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM HEX HEAD SCREW 3.2 MM DIAMETER 33 MM LENGTH; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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 when the circulating nurse opened the package, there was a hole in the 3.5mm 33 headed screw wrapper and the screw was not between the plastic protection sleeve.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Visual evaluation of the provided picture identified an open tyvek lid with a small defect that may be a hole, which cannot be confirmed.There is indication that the product was being used as the package is opened.However, the screw and the plastic sleeve are not visible on the provided picture.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control is considered conforming based on the dhr review but cannot be confirmed.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5 MM HEX HEAD SCREW 3.2 MM DIAMETER 33 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10442026
• Report Number: 0001822565-2020-03013
• Device Sequence Number: 19856855
• Product Code: LXH
• UDI-Device Identifier: 00889024201699
• UDI-Public: (01)00889024201699
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 00590103533
• Device Lot Number: 64744174
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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