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

Model Number N/A

Device Problems Mechanical Problem (1384); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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?.

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 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
• Type of Device: 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
• MDR Text Key: 273758081
• Report Number: 3002806535-2021-00418
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 05019279430475
• UDI-Public: 05019279430475
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1