MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PUNCHER SIZE 3/4; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	02.07.10.1040
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 1656871: (b)(4) items manufactured and released on 10-oct-2017.No anomalies found related to the problem.To date, no similar event has ever been reported on this lot.Clinical evaluation performed by medical affairs director: intraoperative tibial fracture in a (b)(6) year old woman.Intraoperative fractures mainly depend on bone quality and mechanical properties.In this case, sclerotic bone was reported, which has probably created a higher-risk condition.The report does not mention a defect of the devices being detected.
Event or Problem Description
During tibial keel preparation a tibial plateau fracture has occurred, described as vertical pattern of fracture from posterior cortex to anterior one.Treated with 2 screws fixation and tibial stem.The surgeon thinks that this is combination of sclerotic bone and blunt puncher.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: from the visual inspection, the trial keel puncher seems to be suitable for its intended use.The puncher is compatible with standard ones on stock.In case of sclerotic bone it is recommended to prepare the keel wings by using of oscillating saw before to impact the trial keel puncher.

• Brand Name: GMK PUNCHER SIZE 3/4
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8498766
• Report Number: 3005180920-2019-00251
• Device Sequence Number: 14152793
• Product Code: LXH
• UDI-Device Identifier: 07630040758154
• UDI-Public: 07630040758154
• 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): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02.07.10.1040
• Device Lot Number: 1656871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 80