MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM BATTERY, POWER DRIVER DRIVER; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).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 Description

It was reported that during an incoming inspection that foreign material was in the sterile packaging.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Supplied photo shows label 50-1010 lot 436660 which compares to complaint information.Other supplied photo shows black debris within packaging.Debris size acceptability cannot be determined from supplied photos.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.

Event Description

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

• Brand Name: 1.5MM SYSTEM BATTERY, POWER DRIVER DRIVER
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christine arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13934492
• MDR Text Key: 288890437
• Report Number: 0001032347-2022-00100
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00841036063504
• UDI-Public: (01)00841036063504(17)230806(10)436660
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: N/A
• Device Catalogue Number: 50-1010
• Device Lot Number: 436660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1