MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PIN ADAPTOR HUDSON COUPLING - CONICAL ASSEMBLY; KNEE INSTRUMENT PIN ADAPTOR

Model Number	02.07.10.4742
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 september 2021: lot 1953865: (b)(4) items manufactured and released on 11-sept- 2019.No anomalies found related to the problem.To date, no other similar events have been reported.
Event or Problem Description
The pin did not rotate correctly while coupled with the pin adopter.Pin metal debris was observed while inserting it in the tibial cutting guide.The surgeon completed the surgery setting the cut block by visual.30 minutes delay.Total surgery time was 130 minutes.
Additional Manufacturer Narrative
Visual inspection completed by r&d project manager on (b)(6) 2021 during the visual inspection, the pin adapter was checked in standard condition of use.Several motorized pins have been inserted and used to fix metal cutting blocks.The first check was to compare the device with other units from finished goods inventory, with no significant difference detected regarding pin insertion and pin stability.In order to fully evaluate the device, we mesured the triangular connection, which detected a slight offset from the standard specifications, but as the device has been used multiple times we cannot determine to what extent this has been influenced by wear over the useful life of the device.We then proceeded with the visual and functional analysis of the coaxial features during rotation between the pin and the pin adapter; a slight difference was detected when comparing the returned device and units retrieved from finished goods inventory, but no conclusion could be made regarding this.Ultimately, we were able to proceed with the fixation of several cutting blocks to standard sawbones.Although we could not repeat the reported issue, it is possible that the specific combination of pin and pin adapter may have resulted in a omproper rotation of the pin which then led to excessive friction during pin insertion into the cutting guide fixation holes.The pin was then sized due to a cold welding phemomenon.
Additional Manufacturer Narrative
Device returned on 12-november-2021, device evaluation is ongoing.

• Brand Name: GMK-SPHERE PIN ADAPTOR HUDSON COUPLING - CONICAL ASSEMBLY
• Common Device Name: KNEE INSTRUMENT PIN ADAPTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12638399
• Report Number: 3005180920-2021-00809
• Device Sequence Number: 16484667
• Product Code: LXH
• UDI-Device Identifier: 07630040790857
• UDI-Public: 07630040790857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

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: 02.07.10.4742
• Device Catalogue Number: 02.07.10.4742
• Device Lot Number: 1953865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 09/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/10/2021; 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian