MAUDE Adverse Event Report: SYNTHES GMBH 14.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number 03.404.024S

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

Device report from colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2023, the cutter from the ria 2 system was damaged.Upon manufacturer inspection of received images, it was determined that the prongs of the reamer head f/ria 2 ø14 were broken.This report is for a 14.0mm reamer head for ria 2 sterile.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procode: hrx.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a synthes employee.H3, h6: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument release to warehouse date: 16 december 2022.Expiration date: 01 november 2032.Part: 03.404.024s, 14.0mm reamer head for ria 2-sterile.Lot: 3181p27 (sterile).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part: 03.404m024, ria ii reamer head 14.0mm lot: 635p361.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance received from mark two engineering was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Was reviewed and determined to be conforming.Heat treat results certified.Certificate of analysis supplied to mark two engineering from banner medical was reviewed and determined to be conforming.Material certification supplied to banner medical from universal steel was reviewed and determined to be conforming.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 14.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17497750
• MDR Text Key: 320805332
• Report Number: 8030965-2023-10093
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334142467
• UDI-Public: (01)07612334142467
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.024S
• Device Lot Number: 3181P27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1