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	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the shell inserter tip broke and remained in the shell.The surgery was completed with another device and no broken pieces were left in the patient.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00875305801 lot# 65516341 58mm o.D.Size ll porous uncemented with cluster holes shell use with ll liners.G2: foreign ¿ (b)(6).The 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.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4), this follow-up report is being submitted to relay additional information.The following sections were updated/corrected: visual examination of the provided picture identified the tip of the inserter may be fractured, but without a full view of the end of the device it cannot be confirmed if it's fractured.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.The provided picture does not provide a full view of the distal tip.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified strike plate shows indentations from previous uses.Nicks, gouges, and scratches were noted to the device.Threaded tip is confirmed fractured.Fractured piece(s) were not returned with the device for review.No other damage was noted.Root cause unchanged.This complaint was confirmed based on the returned, fractured device.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
No further information is available at the time of this report.

• Brand Name: STRAIGHT SHELL INSERTER
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18141418
• Report Number: 0001822565-2023-03128
• Device Sequence Number: 6588282
• Product Code: LXH
• UDI-Device Identifier: 00889024133945
• UDI-Public: (01)00889024133945(11)190912(10)64318142
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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: 64318142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 09/13/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/12/2023; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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: Reuse
• 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
• Patient Sex: Unknown