MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO SCR 1.5X5MM 1.5 SYS 2PK; CRANIOFACIAL BONE SCREW, BIOABSORBABLE

Catalog Number	915-2316
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distributorship found debris within the sterile packaging.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: lacto scr 1.5x5mm 1.5 sys 2pk, cat# 915-2316, lot# 66239010.G2: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2023 - 00439.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: no product was returned.A visual inspection was conducted on the customer provided picture.The picture shows there is a single piece of debris within the outer packaging.As no product was returned measurements cannot be conducted to confirm if the debris is conforming or not as it could not be determined if the photo is to scale.Per work instructions the debris is to be measured with a calibrated tappi standard t564 (size estimation chart) if needed to estimate the size of the identified particles.The complaint is confirmed.The root cause of the reported issue is attributed to a manufacturing issue.Debris likely resulted from the manufacturing process as event was identified on unopened product but, our evaluation is limited as no product was returned and product acceptability for debris size and acceptability to established inspection criteria cannot be determined from supplied photos.The reported event is confirmed, based on provided photos.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 is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned product.The product arrived sealed in its original packaging.A visual inspection was conducted on the product.A single piece of debris was found inside of the product packaging.The debris is not inside of the sterile package.The product was inspected per criteria.As there is only one single piece of debris the packaging in considered conforming.No problem identified as the product is acceptable per inspection specification.The complaint for the debris is confirmed.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.

• Brand Name: LACTO SCR 1.5X5MM 1.5 SYS 2PK
• Common Device Name: CRANIOFACIAL BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18227591
• Report Number: 0001032347-2023-00438
• Device Sequence Number: 17692900
• Product Code: JEY
• UDI-Device Identifier: 00841036055196
• UDI-Public: (01)00841036055196(17)280803(10)62239010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: Other
• Device Catalogue Number: 915-2316
• Device Lot Number: 66239010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 03/25/2024; 11/06/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/26/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown