MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO 14MM RAPIDFLAP CLAMP; PROSTHESIS, MICROFIXATION

Catalog Number	915-0020
Medical Device Problem Codes	Fracture (1260); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Full establishment name - (b)(6).Report source foreign - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
It was reported approximately three (3) weeks ago, that the product was found broken and missing a disc when the package was opened approximately two (2) years and six (6) months ago.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; d9; g3; g6; h1; h2; h3; h6.Visual of returned product identified two rapidflap outer plates, two rapidflap appliers with one having part of the rapidflap post still engaged, one rapidflap inner plate, and five broken pieces of rapidflap post were returned in one bag.This indicates there are 2 different 915-0020 product pieces within the returned bag.There appears to be blood and debris on a number of the pieces and within the return bag.No packaging was returned.The reported complaint was for a quantity of one.There is nothing on the returned bag that gives any indication to which part/pieces are for subject complaint and what complaint the other part/pieces might be associated with.Follow up information was to unable to clarify the issue.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: LACTO 14MM RAPIDFLAP CLAMP
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11640737
• Report Number: 0001032347-2021-00195
• Device Sequence Number: 11553399
• Product Code: JEY
• UDI-Device Identifier: 00841036053864
• UDI-Public: (01)00841036053864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2023
• Device Catalogue Number: 915-0020
• Device Lot Number: 615410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1