MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM FEMALE HEX SCREW 25 MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - (b)(6).Customer has indicated that the product will 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
It was reported that when the customer opened the package, there was foreign matter inside the sterile package.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Evaluation of the provided pictures noted the presence of a circular translucent speck on the flange of the plastic retainer or inner cavity.It could not be determined whether the foreign substance rested on top of the retainer flange or was stuck between the retainer flange and inner cavity.The lid of the inner cavity was completely peeled off and there is uniform glue remain all over the inner cavity sealing flange.The foreign substance was returned in a plastic bag taped to the retainer, with the whole product and packaging.The products were still packaged within the protective pouch and plastic bag inside the inner cavity underneath the plastic retainer.Reported event is for a packaging issue; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.The likely condition of the products when it left zimmer biomet was conforming to specifications based on the dhr review and evaluation of the returned product.A definitive root cause cannot be identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This report is being submitted to update the initial reporter information with the doctor's name.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 2.5 MM FEMALE HEX SCREW 25 MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9480405
• Report Number: 0001822565-2019-05307
• Device Sequence Number: 572407
• Product Code: HWD
• UDI-Device Identifier: 00889024232532
• UDI-Public: (01)00889024232532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2020

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: 42509902525
• Device Lot Number: 64454607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 04/23/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/08/2020; 04/27/2020
• 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