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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: nurse opened the oxford tray for surgery and realised the hammer was broken in 2 pieces.No patient involvement.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: the product has not been returned for evaluation and the lot number is unconfirmed.Therefore, the investigation has been limited to the information provided, a review of the device history records could not be carried out as the lot number is unconfirmed.A review of complaint history identified 16 additional similar complaints about the reported item.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.Reports were initiated to address the issue that the welding process is not validated in (b)(6) china.The reported item in this complaint, (b)(4), is included in the scope of a capa.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: the nurse opened the oxford tray for surgery and realised the hammer was broken into 2 pieces.No patient involvement.Addi 20 jan 2022.Picture of the item received.No lot number visible.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product identified that the handle has separated from the shaft.The weld appears to show little penetration into the handle.The toffee hammer has been used extensively identified by peening and heavy indentations on the impact face of the hammer head.The hammer has potentially been in the field for approximately 7 years and 6 months.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No further event information available at the time of this report.

• 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: 12907946
• Report Number: 3002806535-2021-00516
• Device Sequence Number: 4815731
• Product Code: HWT
• UDI-Device Identifier: 00880304525658
• UDI-Public: 00880304525658
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

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: ZB15031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/03/2022; 10/10/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/03/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown