MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO SCR 1.5X4MM 1.5 SYS 2PK; CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	915-2315
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: flat titanium pectus bar 11" cat# jp-0110 lot# 283130, l-plt lt reg 2.0 lactosorb sys cat# 915-2102 lot# 638640, battery powerdriver p2 cat# 50-1010 lot# 282330, battery powerdriver p2 cat#50-1010 lot# 282320, battery powerdriver p2 cat#50-1010 lot# 476000, battery powerdriver p2 cat#50-1010 lot# 579610, carroll-girard screw hex-end cat# sp-2693 lot# 818880, lactosorb1.5mm xshapeextplate cat# 915-2423 lot# 832560, battery powerdriver p2 cat# 50-1010 lot# 692220, battery powerdriver p2 cat# 50-1010 lot# 692220, battery powerdriver p2 cat# 50-1010 lot# 003430, battery powerdriver p2 cat# 50-1010 lot# 003380, battery powerdriver p2 cat# 50-1010 lot# 760440, battery powerdriver p2 cat# 50-1010 lot# 657440, battery powerdriver p2 cat# 50-1010 lot# 657440, battery powerdriver p2 cat# 50-1010 lot# 657440, battery powerdriver p2 cat# 50-1010 lot# 760510, battery powerdriver p2 cat# 50-1010 lot# 760350, plate 4 hole with gap 2.0mm cat# sp-2292 lot# 480680, ster trc tf 18.5mm bnt bur pl cat# sp-st-1020b lot# 147140, ster trc 2 xd tf 1.5x4.0mm scr cat# sp-st2-6704 lot# 071120, lacto scr 1.5x5mm 1.5 sys 2pk cat# 915-2316 lot# 728470.Foreign country: (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 - 2021 - 00441, 0001032347 - 2021 - 00442, 0001032347 - 2021 - 00443, 0001032347 - 2021 - 00444, 0001032347 - 2021 - 00445, 0001032347 - 2021 - 00446, 0001032347 - 2021 - 00447, 0001032347 - 2021 - 00449, 0001032347 - 2021 - 00450, 0001032347 - 2021 - 00451, 0001032347 - 2021 - 00452, 0001032347 - 2021 - 00453, 0001032347 - 2021 - 00454, 0001032347 - 2021 - 00455, 0001032347 - 2021 - 00456, 0001032347 - 2021 - 00457, 0001032347 - 2021 - 00458, 0001032347 - 2021 - 00459, 0001032347 - 2021 - 00460, 0001032347 - 2021 - 00461, 0001032347 - 2021 - 00462, 0001032347 - 2021 - 00463.
Event or Problem Description
It was reported there was foreign material found within sterile packaging during incoming inspection.Attempts have been made and additional information on the reported event is unavailable at this time.
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 package.A single hair can be seen inside of the non sterile packaging.This complaint is confirmed.Per the packaging specifications no hair is allowed inside of the packaging.However, there is no risk to the patient as the hair is not within the inner sterile barrier.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.For the returned product the root cause of the reported issue is attributed to manufacturing deficiency.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 1.5X4MM 1.5 SYS 2PK
• Common Device Name: CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12540500
• Report Number: 0001032347-2021-00448
• Device Sequence Number: 4094386
• Product Code: NHB
• UDI-Device Identifier: 00841036055189
• UDI-Public: (01)00841036055189(17)260514(10)727800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012409
• 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
• Report Date (Section B): 03/24/2022

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 Expiration Date: 05/14/2026
• Device Catalogue Number: 915-2315
• Device Lot Number: 727800
• 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: 09/06/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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
• Patient Sex: Unknown