MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LONG THREADED PINS PACK; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.00009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 16 april 2019: long threaded pins pack, (b)(4), lot 189922: (b)(4) items manufactured and released on 23-nov-2018.Expiration date: 2023-11-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Considering the threaded pin diam 3.2 l70 ha3.5 meche triangle: (b)(4): this is the second case reported.(b)(4); this is the first case reported.Clinical evaluation performed by (b)(4): a guide fixation pin broke off during tka surgery and was not retrieved, so it is completely embedded in tibial bone.The final position of the pin appears to be rather unusual, but this may be due to radiographic projections.The material of the pin is surgical grade stainless steel, approved for invasive surgery but not for long-term implantation.However, given the sheltered location and past anecdotically experience, we have no reason to expect significant clinical consequences by its presence.The position and orientation of the tibial component seems to be unaffected by the broken pin.The cause of the event is not of clinical origin.
Event or Problem Description
During the fixation of a tibial recut jig, ine of the long threaded pins broke and remained in the patient during surgery.Fluoroscopy was done intra-operatively to identify the location of the broken instrument in order to remove it, but the surgeon was not able to remove it.
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager: from the analysis of the images it is not possible to identify the real cause of the pin breakage.The position of the pin is incompatible with the direction/position of the holes of the tibia cutting guides; the pin seems located out of the bone in a posterior soft tissue.For this reason we cannot hypothesize the condition of use that generate the device failure.

• Brand Name: LONG THREADED PINS PACK
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8527548
• Report Number: 3005180920-2019-00287
• Device Sequence Number: 2443593
• Product Code: LXH
• UDI-Device Identifier: 07630030842740
• UDI-Public: 07630030842740
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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 Expiration Date: 11/07/2023
• Device Catalogue Number: 11.00009
• Device Lot Number: 189922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Weight: 85