MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DELTA CTA HEAD REAMING GUIDE; EXTREMITY INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Model Number	2307-82-001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device was reviewed and it was noted there were several deep scratches and gauges on both devices.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During preparation of the proximal humerus for the cta head the reamer guide was mounted on to the humeral stem.While reaming with the cta-head-reamer, the reamer suddenly blocked in the reamer-guide.This turned pressure on the humeral stem and generated a fracture of the proximal humerus.This fracture had to be fixed with sutures.The operation could be completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected h6.Medical device problem code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.  h11 additional narrative: corrected: d2b.  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DELTA CTA HEAD REAMING GUIDE
• Common Device Name: EXTREMITY INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 -098
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8252976
• Report Number: 1818910-2019-81088
• Device Sequence Number: 2280163
• Product Code: HWT
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2307-82-001
• Device Catalogue Number: 230782001
• Device Lot Number: 5249135
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/01/2021; 06/29/2026
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/07/2021; 06/29/2026
• Date Device Manufactured: 08/18/2015
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female