MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DELTA CTA HEAD REAMER; EXTREMITY INSTRUMENTS : REAMERS

Model Number	2307-82-003
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988); 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
(b)(4).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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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.H6.Medical device problem code.

• Brand Name: DELTA CTA HEAD REAMER
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8252956
• Report Number: 1818910-2019-81087
• Device Sequence Number: 2189766
• Product Code: LXH
• UDI-Device Identifier: 10603295116356
• UDI-Public: 10603295116356
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 2307-82-003
• Device Catalogue Number: 230782003
• Device Lot Number: 5240939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/19/2019; 03/01/2021
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/20/2019; 03/08/2021
• 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