MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT SLOTTED STEM INSERTER; INSTRUMENT, HIP

Catalog Number	31-555610
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat #: 51-100080/tprlc 133 fp type1 pps so 8.0/lot #: 6800687.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the threaded impactor broke off in the stem.There were no health consequences or impact to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An exact slotted stem inserter, part # 31-555610 from lot 549230, was returned and evaluated against the complaint.Visual inspection found the threaded tip to be fractured.Discoloration and scratching are present on the shaft.The strike plate is in decent condition with minimal scuffing on the surface.One of the nubs at the distal end of the inserter has become deformed and cracked.A review of the device history records identified no related deviations or anomalies during manufacturing.The device is used for treatment.The reported event is not related to a combination of products; therefore a compatibility review is not applicable.A review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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
There is no update to the original complaint description provided.

• Brand Name: EXACT SLOTTED STEM INSERTER
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15627116
• Report Number: 0001825034-2022-02328
• Device Sequence Number: 15077678
• Product Code: LXH
• UDI-Device Identifier: 00880304464148
• UDI-Public: (01)00880304464148(11)191024(10)549230
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 31-555610
• Device Lot Number: 549230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female