MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).Product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip procedure, the lower part of the screw head was fractured when the screw was inserted.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted, to relay additional information.Reported event was unable to be confirmed, due to limited information received from the customer.Device history record was reviewed.And no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 Description

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

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11200976
• MDR Text Key: 227765934
• Report Number: 0002648920-2021-00012
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: 00889024119826
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: 64609716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1