MAUDE Adverse Event Report: BIOMET MICROFIXATION PLATE 4 HOLE WITH GAP 2.0MM; PLATE, FIXATION, BONE

Catalog Number SP-2292

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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, lacto scr 1.5x4mm 1.5 sys 2pk, cat# 915-2315 ,lot# 727800, 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.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.Report source: 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 - 00448, 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 - 00461, 0001032347 - 2021 - 00462, 0001032347 - 2021 - 00463.

Event 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 Description

No further event information is available at the time of this report.

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: PLATE 4 HOLE WITH GAP 2.0MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 12540214
• MDR Text Key: 273571743
• Report Number: 0001032347-2021-00460
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888233015929
• UDI-Public: (01)00888233015929(10)480680
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP-2292
• Device Lot Number: 480680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1