MAUDE Adverse Event Report: SYNTHES GMBH 16.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number 03.404.028S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in colombia as follows: it was reported that during a procedure on (b)(6) 2023, surgeon felt resistance while reaming to remove the graft.The reamer broke while taking it out.Therefore surgeon proceeded to extract it with the olivate guide.While removing the reamer the patient is left with residues of the reamer, which required additional surgical time to remove the reamer fragments.This report is for one (1) 16.0mm reamer head for ria 2 sterile this is report 1 of 1 for complaint (b)(4).

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

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: h3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history review (dhr): manufacturing location: supplier ¿ fathom / inspected and packaged by: monument release to warehouse date: 28-jun-2023 expiration date: 01-jun-2033 part number: 03.404.028s, 16.0mm reamer head for ria 2-sterile lot number: 6505p00 (sterile) lot quantity: 50 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.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 number: 03.404m028, ria ii reamer head 16.0mm lot number: 4452p49 lot quantity: 159 inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance received from fathom dated 05-may-2023 was reviewed and determined to be conforming.Certification for heat treat supplied to fathom from vacu-braze inc.Dated (b)(6) 2023 was reviewed and determined to be conforming.Heat treat certified to be within specified range.Certificate of compliance supplied to (b)(6) from boston centerless dated (hand-written) (b)(6) 2021 was reviewed and determined to be conforming.Material certification supplied to boston centerless from carpenter dated (b)(6) 2021 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.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: 16.0MM 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18251689
• MDR Text Key: 330670576
• Report Number: 8030965-2023-15227
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334142504
• UDI-Public: (01)07612334142504
• 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: Physician
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.028S
• Device Lot Number: 6505P00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1