MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TOFFEE HAMMER; BMET GENERAL KNEE INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the head of the toffee hammer broke away from the handle.The doctor used the hospital hammer to complete any further hammering.No delay - no harm to the patient.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Due to lack of information, it is unknown whether the device will be returned to zimmer biomet for investigation at this time.When this information is known, it will be provided in a follow-up report.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up document is being submitted to relay supplemental information.Supplemental information acquired: item lot number, hospital address.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.
Event or Problem Description
It was reported, that: the head of the toffee hammer broke away from the handle.The doctor used the hospital hammer to complete any further hammering.No delay - no harm to the patient.Addi 22 feb 2022: 1.Lot number for the toffee hammer: 0086.2.Hospital name where the reported event occurred: (b)(6).
Event or Problem Description
It was reported, that: the head of the toffee hammer broke away from the handle.The doctor used the hospital hammer to complete any further hammering.No delay - no harm to the patient.Addi 22 feb 2022: 1.Hospital name where the reported event occurred: (b)(6) clinic.
Additional Manufacturer Narrative
(b)(4).This follow-up document is being submitted to relay corrected information.Lot number corrected.The new lot number presented in the previous report was in error.The lot number for this complaint is still unknown.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: lot number: zb160602.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: the head of the toffee hammer broke away from the handle.The doctor used the hospital hammer to complete any further hammering.No delay - no harm to the patient.
Additional Manufacturer Narrative
(b)(4).Complaint summary: adequate photographs have not been provided and the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified 18 additional similar complaints about the reported item and 1 additional complaint about the reported item and lot combination this device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It cannot be confirmed that the instrument is not within the scope or subject of any field actions or recalls which could be attributed to the reported events as the lot number is unknown.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event can be confirmed as relevant photographs have been provided but the product has not been returned for evaluation.The root cause of the reported event cannot be determined with the information provided.Corrective action and/or preventative action: a capa was initiated to address the issue that the welding process is not validated in jinhua, china.The reported item in this complaint, 32-422760, is included in the scope of the capa.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: the head of the toffee hammer broke away from the handle.The doctor used the hospital hammer to complete any further hammering.No delay.No harm to the patient.Addi 22 feb 2022: 1.Lot number for the toffee hammer: 0086.2.Hospital name where the reported event occurred: (b)(6) clinic.Addi 23 feb 2022: lot number mentioned in addi388138 is incorrect - it is a ce number.There is unfortunately no other visible number on the toffee hammer.Addi 24 feb 2022: on closer inspection with a magnifying glass, there is visible number zb160602 - lot # for toffee hammer.

• Brand Name: OXF UNI TOFFEE HAMMER
• Common Device Name: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13576309
• Report Number: 3002806535-2022-00072
• Device Sequence Number: 14115137
• Product Code: LXH
• UDI-Device Identifier: 00880304525658
• UDI-Public: 00880304525658
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/11/2022

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: 32-422760
• Device Lot Number: ZB160602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 03/10/2022; 03/10/2022; 03/10/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 02/23/2022; 02/23/2022; 02/25/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (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
• Patient Sex: Unknown