MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC+ QK CONNECT ACET FLX DRL; HIPS, INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: australia.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.Not returned to manufacturer.
Event or Problem Description
It was reported there was a broken instrument on tray.There was no patient involvement.Attempts have been made and further information has been provided.
Event or Problem Description
It was reported the instrument was broken upon inspection before the surgery had started.The broken instrument is a case of wear and tear and there is no confirmation on when the instrument broke.The same device from a different tray was used to complete the case.The was no patient involvement reported.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified the silicon cover has been torn off.The head of the driver appears to be twisted and has wear lines.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item(s) and part and lot combination(s).Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RNGLC+ QK CONNECT ACET FLX DRL
• Common Device Name: HIPS, INSTRUMENT
• 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: 16139518
• Report Number: 0001825034-2023-00062
• Device Sequence Number: 17803501
• Product Code: HTW
• UDI-Device Identifier: 00880304452565
• UDI-Public: (01)00880304452565(11)17602(10)164905
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 31-424204
• Device Lot Number: 164905
• Was Device Available for Evaluation?: No
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• 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
• 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