MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.022S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hrx d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.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.
Event or Problem Description
It was reported that on (b)(6) 2023, the ria2 reamer head broke while reaming left tibia.Ria2 tube assembly was damaged when reamer head failed.Both items were no longer usable, new items were opened to complete the case.Attending speculation is it may have been due to resident inadvertently starting to ream in the reverse direction.Fragments from reamer head were too deep to remove.They were retained in the tibial canal.There was a surgical delay of 10 minutes.The procedure was completed successfully.There is no indication that the delay resulted in any impact to the expected surgical outcome this report is for one (1) 13.0mm reamer head for ria 2 sterile this is report 1 of 1 for complaint (b)(4).
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.Manufacturing location: supplier ¿ (b)(4) / inspected and packaged by: monument.Release to warehouse date: 26-mar-2020.Expiration date: 01-mar-2030.Part number: 03.404.022s, 13.0mm reamer head for ria 2-sterile.Lot number: 46p3577 (sterile).Production order traveler 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 supplied 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.M022, ria 2 reamer head 13.0mm.Lot number: 6911015.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, rev b met all inspection acceptance criteria.Certificate of compliance received dated 24-jan-2020 was reviewed and determined to be conforming.Certification for heat treat dated 19-dec-2019 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 54 hrc.Certificate of compliance dated 04-sep-2019 was reviewed and determined to be conforming.Raw material certification dated 12-jun-2019 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.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 or Problem Description
The damage to the tube assembly is currently unknown.There is insufficient information to determine if there is any reportable device malfunction associated with the kit apart from the known reamer failure.

• Brand Name: 13.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: 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: 16748628
• Report Number: 8030965-2023-04686
• Device Sequence Number: 15592478
• Product Code: HTO
• UDI-Device Identifier: 10886982274021
• UDI-Public: (01)10886982274021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 03.404.022S
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 46P3577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Sex: Male
• Patient Weight: 83 KG