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

Catalog Number 03.404.001S

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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.Only the event year is known.Additional device product codes: hrx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 chile as follows: it was reported that on an unknown date, there were problems with the ria2.The piece broke when the doctor was reaming.He couldn¿t continue.The surgery was delayed, but successfully completed.There was no patient consequence.No further information is available.This report involves one ria 2 reaming kit 520mm sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photo.Visual analysis of the photo revealed that the ria 2 reaming kit l520 appears to have both the yellow reaming rod seal and the coupling receiver of the manifold melted in the shaft of the device.There are no signs of breakage within the device.The ria 2 surgical technique guide was reviewed.Following relevant statements were found.Caution: do not use drill with torque greater than 6 nm.Do not use a reduction drive.Do not use power driver designed for reaming.Never ream when there is no irrigation/aspiration.The irrigation/aspiration fluid cools the reamer head and removes bone marrow and morselized bone from the medullary canal.Fluid flow is crucial for proper system performance.Note: do not turn the power on when the drive shaft is disengaged from the tube assembly.While no definitive root cause can be determined for the reported issue, the melting condition of the seal and the receiver was consistent with a component failure that may have been caused by exposure to unintended forces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the ria 2 reaming kit l520.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: a device history record (dhr) review was conducted: manufacturing location: packaged, sterilized and released by: monument; release to warehouse date: 17-jun-2022; expiration date: 01-jun-2023; part number: 03.404.001s, ria 2 reaming kit 520mm sterile; lot number: 884p133 (sterile); lot quantity: (b)(4).Production order traveler 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 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: 643p095; lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance dated 13-jan-2022 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set; lot number: 853p475; lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certificate of compliance dated 12-may-2022 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Part number: 03.404m001, rmg rod/drive shaft packaged; lot number: 858p329; lot quantity: (b)(4).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: 681p248; lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance dated 28-jan-2022 was reviewed and determined to be conforming.Part number: 03.404m003, manifold assembly packaged; lot number: 884p078; lot quantity: (b)(4).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: 820p452 ; lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance dated 25-apr-2022 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 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: RIA 2 REAMING KIT 520MM 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15986787
• MDR Text Key: 308494785
• Report Number: 8030965-2022-11148
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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 Expiration Date: 06/01/2023
• Device Catalogue Number: 03.404.001S
• Device Lot Number: 884P133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1