MAUDE Adverse Event Report: BIOMET MICROFIXATION STR PLT 8HLE 2.0 LACTOSORB SYS; CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE

Catalog Number 915-2108

Device Problem Packaging Problem (3007)

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

Event Date 05/17/2021

Event Type  malfunction  

Event Description

It was reported that there were some stains in the packages found in the china warehouse.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Lactosorb1.5mm4holeextstrplate cat# 915-2414 lot# 392900 report source: (b)(4).-two unopened products were returned with label information item# 915-2108 lot# 819430 and item# 915-2414 lot# 392900 and verified to complaint information.Based on photos supplied from complainant it appears the reported issue could be for debris attached to the heat dots.Visual evaluation of both products identified no stains on either of the returned products.There is black hair/ fiber present and is stuck to the temperature indicator dot inside both of the returned unopened packages.These are not acceptable per inspection criteria.-review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.-the condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2021 - 00543.

• Brand Name: STR PLT 8HLE 2.0 LACTOSORB SYS
• Type of Device: CRANIOFACIAL FIXATION PLATE, 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12960090
• MDR Text Key: 285231358
• Report Number: 0001032347-2021-00542
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036054528
• UDI-Public: (01)00841036054528(17)260115(10)819430
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955729
• 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
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 915-2108
• Device Lot Number: 819430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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