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

Model Number 03.404.016S

Device Problems Break (1069); Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/07/2021

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Correction/removal number: 3008812560-10/26/2020-001-c.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent a procedure using an expert tibial nail (etn).It was a very narrow canal of 8mm, so surgeon wanted to go with a sharp and one stage ria2 reamer.During procedure the surgeon was not satisfied with the design of reamer/irrigator/aspirator (ria) 2 as it snapped during the case.There was a breakage of ria 2 head snapping off inside patient whilst being used.The small pieces were left in patient's intramedullary canal but surgeon didn¿t believe that it will cause a problem to the patient.The surgery was delayed for ten (10) minutes due to the reported event.The procedure was completed by using standard synream instead of ria2.No further information provided.This report is for one (1) 10.0mm reamer head for ria 2 sterile.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: (b)(4); release to warehouse date: 25-jan-2020; expiration date: 01-jan-2030; part number: 03.404.016s, 10mm reamer head for ria 2-sterile; lot number: 37p6516 (sterile); lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log 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 met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Certification for heat treat was reviewed and determined to be conforming.Raw material certificate of analysis was reviewed and determined to be conforming.Raw material certification was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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 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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12422617
• MDR Text Key: 269812858
• Report Number: 8030965-2021-07492
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• 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
• Report Date: 08/07/2021

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 Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 37P6516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/12/2021
• Patient Sequence Number: 1
• Treatment: RIA 2 REAMING KIT L520.; RIA 2 REAMING KIT L520
• Patient Outcome(s): Required Intervention