MAUDE Adverse Event Report: BIOMET UK LTD. ARCOS LT TARGET ARM; ARCOS INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Example 2: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location unknown.
Event or Problem Description
It was reported via a zimmer biomet arcos ils survey that the arcos target arm was not accurate in aiming/placement screw in one case.Dr (b)(6) wondered whether it was due to a technical mistake or not enough intramedullary reaming?.
Additional Manufacturer Narrative
(b)(4), this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: product has not been returned for evaluation, therefore the investigation has been limited to the information provided.A dhr review could not be performed as the lot number has not been provided.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.Review of complaint history identified no additional similar complaints for the reported item number in the last 3 years.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to reported event.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Capa: no corrective or preventive action required at this time.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.Device location unknown.
Event or Problem Description
It was reported via a zimmer biomet arcos ils survey that the arcos target arm was not accurate in aiming/placement screw in one case.Dr supit wondered whether it was due to a technical mistake or not enough intramedullary reaming?.

• Brand Name: ARCOS LT TARGET ARM
• Common Device Name: ARCOS 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: 12545486
• Report Number: 3002806535-2021-00418
• Device Sequence Number: 19110881
• Product Code: KWA
• UDI-Device Identifier: 05019279430475
• UDI-Public: 05019279430475
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100469
• 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): 01/13/2022

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: 31-301901
• Device Lot Number: UNKNOWN
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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