MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANT BONE RMVL SHAFT-OUTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report: report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: oxf ant bone rmvl shaft-inner, catalog #: 32-423232, lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426.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 spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.
Event or Problem Description
It was reported, that the spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.Another instrument was used to complete the surgery.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Gender : female, age :57, lot number : zb150701.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426-1.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00426-2 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot number identification is necessary for review of device history records, it was provided.A review of the complaint database over the last 3 years has found 25 similar complaints reported with the item 32-423233 (including initiating complaint, and 27 similar complaints reported with the item 32-423233 (including initiating complaint, the outcome from hhed-2016-005 was that no hhe was required.Without the opportunity to examine the complaint product, a definitive root cause cannot be determined due to insufficient information.The most likely underlying cause is the contact between the two surfaces causing fretting and binding.No corrective or preventative actions are required at this time.If any additional information becomes available, then the complaint will be reopened and further investigated.
Event or Problem Description
It was reported, that the spring jammed/stuck inside the anterior reamer shaft.The surgeon had to adjust to the stuck spring causing him to ream 1mm too far anteriorly.Another instrument was used to complete the surgery.

• Brand Name: OXF ANT BONE RMVL SHAFT-OUTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12554319
• Report Number: 3002806535-2021-00427
• Device Sequence Number: 14476828
• Product Code: HXC
• UDI-Device Identifier: 05019279447992
• UDI-Public: 05019279447992
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2021

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 Model Number: N/A
• Device Catalogue Number: 32-423232
• Device Lot Number: ZB150701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 12/23/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/22/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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 Age: 57 YR
• Patient Sex: Female