MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STRAIGHT SHELL INSERTER; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) report source: (b)(6).Has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03880.
Event or Problem Description
It was reported that the tip of the inserter broke off while inserting shell.No harm was done to the patient or the impact.The tip of the inserter was retrieved and discarded.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 -2021-00180.
Event or Problem Description
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 -2021-00180.

• Brand Name: STRAIGHT SHELL INSERTER
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12024259
• Report Number: 0001822565-2021-01677
• Device Sequence Number: 4257307
• Product Code: LXH
• UDI-Device Identifier: 00889024133945
• UDI-Public: (01)00889024133945(10)63490653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00780401520
• Device Lot Number: 63490653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1