MAUDE Adverse Event Report: BIOMET MICROFIXATION CRILE-WOOD NH FINE TC STR 6"; HOLDER, NEEDLE; ORTHOPEDIC

Catalog Number 51-6507

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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

It was reported that the tip of the device chipped.No adverse consequences have been reported for this event.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of the returned device, it was determined to be not reportable.The item originally reported has previously caused or contributed to a serious injury; however, the returned device is a different item.After reassessment, the returned item has not previously caused or contributed to a serious injury; therefore, is not reportable.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: CRILE-WOOD NH FINE TC STR 6"
• Type of Device: HOLDER, NEEDLE; ORTHOPEDIC
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16919415
• MDR Text Key: 315093230
• Report Number: 0001032347-2023-00161
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 00841036048570
• UDI-Public: (01)00841036048570(10)C09
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Catalogue Number: 51-6507
• Device Lot Number: C09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/23/2023
• 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
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose