MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 11MM X 400MM; PROSTHESIS, TRAUMA

Catalog Number 814311400

Device Problem Mechanical Jam (2983)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03170.Concomitant medical products: item# 211201202; lot# unk.Item# 211201200; lot# unk.Report source: foreign - event occurred in (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.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 surgeon completed a hip fracture nailing operation using the affixus hfn.At the end of the procedure, the jig connecting bolt was unable to be removed from the nail.They ended up using two trays and the handle of insertion jig instrument broke.In the end they had to remove the whole prosthesis and open a third set and new nail to complete the surgery.There was a delay in the procedure of an unknown time.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 visual examination of the provided pictures identified the nail is still connected to the targeting jig.The insertion jig bolt is not visible in the provided pictures.Part and lot information cannot be confirmed.Medical records were not provided.Review of the device history record(s) for part 814311400 identified no deviations or anomalies during manufacturing related to the reported event.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: HFN RH 125 DEG 11MM X 400MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12844258
• MDR Text Key: 281016743
• Report Number: 0001825034-2021-03169
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868038167
• UDI-Public: (01)00887868038167(17)310617(10)014900
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 814311400
• Device Lot Number: 014900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose