MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH; INSTRUMENT, HIP

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	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(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 follow-up mdr will be submitted.
Event or Problem Description
It was reported by the distributorship that the products were found to be nonconforming.No products in the package.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
visual review of the provided photographs identified the following: the pin was missing in the closed tube.There is no tamper evident seal on the product, therefore it cannot be confirmed this product left zimmer biomet nonconforming.No further evaluation is possible with the images provided.The packaging of a modular flex drill bit was returned.Visual evaluation identified the following: the tube did not contain the drill bit.The blue caps were correctly attached with foam end cap inside the tube.There was no damage to the tube or caps.No further evaluation could be performed with the returned product.Review of the device history records and receiving inspection report identified no deviations or anomalies during manufacturing.Supplier's device history records were not reviewed as the reported event is related to packaging process that is performed at zimmer biomet.Review of the rir confirmed that all products of the lot were accepted by zimmer biomet.Medical records were not provided.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11934950
• Report Number: 0001822565-2021-01507
• Device Sequence Number: 4344916
• Product Code: LXH
• UDI-Device Identifier: 00889024152212
• UDI-Public: (01)00889024152212(10)65088230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 09/10/2021

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: 00879000703
• Device Lot Number: 65088230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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