MAUDE Adverse Event Report: BIOMET MICROFIXATION BATTERY POWERDRIVER P2; 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  

Event Description

It was reported that during receiving inspection foreign material was discovered in the sterile package.

Manufacturer Narrative

(b)(4).Concomitant medical products: battery powerdriver p2,cat #5050-1010, lot # 147260.Battery powerdriver p2,cat #5050-1010, lot # 386850.Battery powerdriver p2,cat #5050-1010, lot # 407260.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00509, 0001032347-2021-00510, 0001032347-2021-00511.Report source: (b)(6).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned.Photos were provided and the following was identified: item# 50-1010 lot# 147280 was verified item/lot to complaint.Three photos were reviewed and identified white debris, red debris, and white debris.Size cannot be verified.Inspection criteria i00051.3 packaging inspect outlines acceptable standards for packaging debris within packaging requirements section.Debris size acceptability cannot be determined from supplied photos.Review of the device history record(s) identified no deviations or anomalies during manufacturing 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.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, g3, g6, h2, h3, h6 and h10.Correction information: d4.

Event Description

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

• Brand Name: BATTERY POWERDRIVER P2
• 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: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12820056
• MDR Text Key: 282332662
• Report Number: 0001032347-2021-00508
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00841036063504
• UDI-Public: (01)00841036063504
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 50-1010
• Device Lot Number: 147280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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
• Treatment: SEE H10