MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM HT SD X-DR SCR 5-PK; PROSTHESIS, MICROFIXATION

Catalog Number	95-6104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that the screw broke during surgery approximately two (2) years and one (1) months ago.Attempts have been made and no further information has been provided.
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.The product was returned, however, it was lost before complaints was able to investigate.No pictures were provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: two pieces were scrapped at op seq 0101 for common cause scrap.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 1.5X4MM HT SD X-DR SCR 5-PK
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11640680
• Report Number: 0001032347-2021-00194
• Device Sequence Number: 11553398
• Product Code: JEY
• UDI-Device Identifier: 00841036056650
• UDI-Public: (01)00841036056650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121589
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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 Catalogue Number: 95-6104
• Device Lot Number: 532650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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