MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE GENERAL SET; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: gmk sphere general set, ref 11.01002, lot 1901027: (b)(4) items manufactured and released on 27-feb-2019.Expiration date: 2024-02-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Considering the specific component femoral impactor/ extractor, ref77.11.0063, lot mat27910 ((b)(4) pieces): this is the 4th case received for the breakage of the central body.Additional item involved in the event (same issue, different lot): gmk sphere general set, ref 11.01002, lot 1810920: (b)(4) items manufactured and released on 16-jan-2019.Expiration date: 2024-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Considering the specific component femoral impactor/ extractor, ref77.11.0063, lot mat26932 ((b)(4) pieces): this is the 2nd case received for the breakage of the central body.The other complaint is [(b)(4)].Visual inspection performed by r&d project manager: from the visual inspection it is not possible to identify the real cause of the breakage because of the lack of the broken part.We can imagine that the breakage could be happened due to excessive tightening force applied during femoral implant fixation and, as reported on the complaint form, the surgeon tried to adjust the flexion of the femoral component.
Event or Problem Description
When the surgeon impacts the trial femoral component, two femoral impactor broke (central body).The reason for the breakage is that the force was applied to correct the flexion of the trial femoral component.The surgery was completed with another company's instrument which was stored at the hospital.

• Brand Name: GMK SPHERE GENERAL SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8673856
• Report Number: 3005180920-2019-00448
• Device Sequence Number: 19460722
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 02/14/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1901027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/06/2019
• 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: 56 YR