MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALOCK INSTRUMENTS PEEK Ø2.9 - LONG DRIVER; INSTRUMENT FOR ARTHROSCOPIC SURGERIES

Model Number	05.11.002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2227487: (b)(4) items manufactured and released on 06-feb-2023.Expiration date: 2027-dec-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 1 month after the primary surgery, the surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Event or Problem Description
During anchor insertion, the surgeon felt like a lot of force was required to mallet into bone.Once the anchor was fully implanted, the introducer came away from the anchor immediately (without need for counterclockwise turns).The broken tip of the inserter (ref.66.01.010; mat 33775) was visible in the intraoperative xray.It is feasible that, during the malleting phase, the anchor and the inserter were not fully axially aligned with the pilot hole and that the malleting was not fully axially aligned with the handle of the inserter.Slotted aimer was not used.The tip was left inside the patient.Suture fixation was adequate and surgeon used 2 more jlock anchors successfully following and 1 prior to the breakage.No revision surgery is planned.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: while inserting an anchor in hip arthroscopy surgery, the surgeon reported the breakage of the introducer tip, after feeling hard insertion.As shown by the intra operative x ray at our disposal, the metallic tip of the instrument remained sitting into the bone.Even though the material of the instrument is medical grade stainless steel it does not belong to the series approved for long term implantation and therefore we cannot guarantee that leaving the fragment in situ may not cause secondary problems.However, given that in this case the fragment is completely surrounded by bone, it is extremely unlikely that secondary adverse effect can never be triggered.Retrieving the fragment would undoubtedly be very invasive a procedure and therefore the surgeon has understandably decided to leave it in place.It is difficult to determine the cause of this breakage, but report indicates that the patient may have had sclerotic bone which made insertion difficult.With the information at hand, we cannot make a definitive conclusion.Visual inspection performed by r&d manager: the breakage of the inserter occurred in correspondence of the change of section between the distal cylindrical portion and the thread, leaving the most distal pin (thread + cone) within the peek anchor.The breakage at this section suggests that the assembly inserter and anchor has been subjected to considerable lateral loads.As confirmed by the event reporter, the direction of insertion was not correspondant with the pilot hole axis suggesting a misalignment between the inserter and the bone.Hammering the inserter in this configuration may result in a non forseeable lateral hitting load condition, bringing to the weakest section breakage.A preliminary microscopic analysis of the cross broken section suggests an instantaneous failure, compatible with a hammering action therefore excluding a cyclic load condition.The constrained condition of the pilot hole prevented the anchor to fail (internally also supported by the metal pin) concentrating the loads on the interface section between anchor and inserter.

• Brand Name: MECTALOCK INSTRUMENTS PEEK Ø2.9 - LONG DRIVER
• Common Device Name: INSTRUMENT FOR ARTHROSCOPIC SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17361571
• Report Number: 3005180920-2023-00549
• Device Sequence Number: 6041478
• Product Code: MBI
• UDI-Device Identifier: 07630040727815
• UDI-Public: 07630040727815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 05.11.002
• Device Catalogue Number: 05.11.002
• Device Lot Number: 2227487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2023
• Supplement Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male