MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXTRACTOR ADAPTER; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 574201085 ¿ avenir stem ¿ 3102389.The product is in process of being returned to zimmer biomet for the investigation.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a right hip revision, the surgeon was attempting to remove the stem when the connecting bolt for the slap hammer sheared off.The stem was not able to be removed and the broken piece of the instrument remained in the wound.The surgeon decided to leave the stem implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 visual examination of the returned product identified it is confirmed that the thread is fractured and partly missing.The part also shows wear and damage.Additionally, the device was submitted for further analysis.Analysis determined the fracture revealed river lines artifacts all flowing in one direction towards a suspected hinge at its edge, suggesting a bending overload mode of fracture.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: multiple attempts made to explant the stem with a backslap hammer and osteotomes, stem well fixed and unable to be removed, surgeon elected to leave the stem rather than eto.At this point, the back slapping attachments broke off in the stem with only the threads being full of the metal of the extraction device and no prominent portion of the back slapper to be grasped in order to be removed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 additional event information to report at this time.

• Brand Name: EXTRACTOR ADAPTER
• Common Device Name: HIP INSTRUMENT
• 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: 16408426
• Report Number: 0001822565-2023-00421
• Device Sequence Number: 6326886
• Product Code: LZO
• UDI-Device Identifier: 00889024509825
• UDI-Public: (01)00889024509825(10)64666143
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K182048
• 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): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 574777110
• Device Lot Number: 64666143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• 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: 01/28/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male