MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MONOBLOCK INSERTER HANDLE; INSTRUMENT, HIP

Catalog Number	110024780
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical devices: item # 31-301852/ arcos 3.5mm hex drive/ lot # zb170703; item # 31-3018521/ arcos 3.5mm hex drive/ lot # z18i0975.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00458, 0001825034 -2021 -00459.
Event or Problem Description
It was reported that upon inspection the tips of the instruments were chipped making them unusable.No patient involvement was noted.Attempts have been made and additional information on the reported event is unavailable at this time.
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 updated: g3; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.One arcos 3.5mm hex drive (zb170703), one arcos 3.5mm hex drive (z18i0975), and one monoblock inserter handle (040960) was returned and evaluated.Upon visual inspection there was scuffing on the strike plate of the inserter and the threaded tip had fractured.Both tips of the hex drives had fractured and there were wear marks on the shaft of the devices.The hex drivers were submitted for fracture analysis.Fracture surface artifacts suggest the torsional overload failure mode.Xrf analysis found both hex drivers material to be consistent with 440 stainless steel alloy.Device history record (dhr) was reviewed and no discrepancies were found.A supplier dhr was not requested as the rir showed material conformance, the device shows signs of multiple use, and the device has a potential field age of approximately 2 years.Root cause of the event could not 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.

• Brand Name: MONOBLOCK INSERTER HANDLE
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11324335
• Report Number: 0001825034-2021-00460
• Device Sequence Number: 19865087
• Product Code: LXH
• UDI-Device Identifier: 00880304700482
• UDI-Public: (01)00880304700482(11)180104(10)040960
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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 Catalogue Number: 110024780
• Device Lot Number: 040960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10