MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 REAMING KIT 520MM STERILE; REAMER

Catalog Number	03.404.001S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
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: b3: unknown event date.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 an unknown date during an unknown procedure, surgeon was reaming with ria2 via infrapatellar approach.The tip of the plastic shaft became mangled and had to be replaced by another sterile kit.This report is for ria 2 reaming kit 520mm sterile for (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.H4, h6 manufacturing location: packaged, sterilized and released by: monument release to warehouse date: 20-jul-2023, expiration date: 30-jun-2024, part number: 03.404.001s, ria 2 reaming kit 520mm sterile, lot number: 7054p97 (sterile).Production order traveler met all inspection acceptance criteria.Packaging label log (pll), lppf rev b, lmd rev b was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404m014, irrigation tubing set, lot number: 5722p33.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073691 rev a met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4) medical products dated 31-mar-2023 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set, lot number: 5895p63.Inspection instruction met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4) medical products dated 13-apr-2023 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns073692 rev a met all inspection acceptance criteria.Part number: 03.404m001, rmg rod/drive shaft packaged, lot number: 7145p82.Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m012, ria ii ream rod/dr shaft seal.Lot number: 6650p40, inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073695 rev a met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 02-jun-2023 was reviewed and determined to be conforming.Note: certificates of conformance for roechling subcontractors were included in the dhr.Part number: 03.404m003, manifold assembly packaged, lot number: 7146p32.Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m010, ria ii manifold assembly, lot number: 6745p15.Inspection instruction met all inspection acceptance criteria.Inspection certificate, 03.404m010-2-btq957412 / 1, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 07-jun-2023 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: RIA 2 REAMING KIT 520MM 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: 18210295
• Report Number: 8030965-2023-14848
• Device Sequence Number: 20683152
• Product Code: HTO
• UDI-Device Identifier: 10886982274229
• UDI-Public: 10886982274229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993335
• 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: 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 03.404.001S
• Device Lot Number: 7054P97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown