MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number 03.404.016S

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

Patient Problems Failure of Implant (1924); Injury (2348); Foreign Body In Patient (2687)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2020.Additional procode: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that while reaming during a bone graft, the ria2 10mm reamer head broke.It was discarded and a new reamer head was provided at the surgeon¿s request.Information from the hospital suggests that the reamer head left fragments in the patient, which were unable to be retrieved with suction.Procedure was completed successfully.Patient status is unknown.This report is for a 10.0mm reamer head for ria 2.This is report 1 of 1 for (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.The complaint condition cannot be confirmed, since only the label of the product was on the received pictures.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 lot: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument release to warehouse date: jan 25, 2020, expiration date: jan 01, 2030, part number: 03.404.016s, 10mm reamer head for ria 2-sterile, lot number: 37p6516 (sterile), lot quantity: 50.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns015678 rev f met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17172 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: 03.404.M016, lot number: 6778001 , lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073690 met all inspection acceptance criteria.Certificate of compliance received from mark two engineering dated june 28, 2019 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated oct 14, 2019 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 54 hrc.Raw material certificate of analysis supplied to mark two engineering by banner medical dated mar 26, 2019 was reviewed and determined to be conforming.Raw material certification supplied to banner medical by universal stainless dated dec 14, 2018 was reviewed and determined to be conforming.Device history review nov 09, 2020: dhr reviewed.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.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: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10811584
• MDR Text Key: 217443157
• Report Number: 8030965-2020-08780
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334142382
• UDI-Public: (01)07612334142382
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 37P6516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/01/2020; 12/04/2020; 10/15/2021
• Supplement Dates FDA Received: 12/01/2020; 12/29/2020; 10/15/2021
• Removal/Correction Number: Z-0571-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention