MAUDE Adverse Event Report: BIOMET MICROFIXATION BATTERY POWERDRIVER P2; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 50-1010

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# 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.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.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 - 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 - 00460, 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.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The power driver battery is a single-use item that comes pre-sterilized.This battery is opened on the back table prior to the patient entering the or as a part of the initial room set up.If an additional battery is needed during the procedure, the circulator will open the package to the scrub at the back table.The packages are inspected prior to opening, and if debris is identified in the package, the product is not used.As there is no patient involvement, there is no concern for patient impact (from an or perspective).Product is 100% inspected prior to release from zimmer biomet.Allegations are found in a distributor's incoming inspection and not involved in a procedure - inspection criteria may differ from zb's internal criteria.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• 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: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12540564
• MDR Text Key: 279642250
• Report Number: 0001032347-2021-00444
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• 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: 02/10/2022

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: 50-1010
• Device Lot Number: 282320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10