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

Catalog Number	814311400
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 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; 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
• Common Device Name: 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
• Report Number: 0001825034-2021-03169
• Device Sequence Number: 4351334
• Product Code: HSB
• UDI-Device Identifier: 00887868038167
• UDI-Public: (01)00887868038167(17)310617(10)014900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose