MAUDE Adverse Event Report: JJGC S.A. LATERAL CUT DRILL ZYGOMA-S 4.0X71MM

Catalog Number	103.619
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Foreign Body In Patient (2687)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint was received n which the customer reported an intraoperative incident involving item 103.619 (multifluted zygoma-s bur, lot ykwx5).According to the practitioner's report, the multifluted bur fractured, resulting in the bur becoming lodged within the patient's left maxillary sinus.However, the product safety management and product research & development departments conducted the relevant investigations and concluded that the item's drilling guide pin had unscrewed and detached.
Additional Manufacturer Narrative
Post market surveillance data confirms that the benefit-risk ration maintains acceptable and will keep investigating occurrences related to this product.An internal capa will be started to feedback risk management as necessary, prepare pms process to track new occurrences and check for improvements opportunities in production process or design related.Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.

• Brand Name: LATERAL CUT DRILL ZYGOMA-S 4.0X71MM
• Common Device Name: LATERAL CUT DRILL ZYGOMA-S 4.0X71MM
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; +1(978)747-2509
• MDR Report Key: 50307340
• Report Number: 3008261720-2026-004418
• Device Sequence Number: 15983803
• Product Code: DZA
• UDI-Device Identifier: 07899878059820
• UDI-Public: 07899878059820
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 103.619
• Device Lot Number: YKWX5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2026
• 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: Required Intervention
• Patient Sex: Male