MAUDE Adverse Event Report: SYNTHES GMBH RIA DRIVESHAFT L360; REAMER

Catalog Number	314.742
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the ria was assembled with the ria 360 drive shaft and the 12mm trimming head, which broke at the moment of reaming the femoral canal.Afterward, they passed the 13mm trimming head which was mounted on the ria 520 to continue the extraction of graft from the canal.The head and proximal part of the driving shaft were split again.It was not possible to remove the hose system of the ria l360 from its drive shaft, so it was covered with latex gloves.The procedure was not a success.The surgeon was not able to remove the required graft and the wound was closed.Due to the damage of the two milling cutters and the drive shaft, it was not possible to take the graft that the patient needed to fill the defect because it was a reconstructive surgery that required a second surgical time, with the possibility and risk of infection.This report involves ria driveshaft l360 this is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional product code: hrx, part # 314.742, synthes lot # h730294, supplier lot # h730294, release to warehouse date: 22 feb 2019, supplier: (b)(4).No non conformance reports were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the shaft of the ria driveshaft l360 was observed bent.Assembling issues are most likely due to this condition.In addition, the sleeve was observed cracked at the body and broken at the distal tip, the fragment was not received in the evidence provided.A dimensional inspection for the ria driveshaft l360 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the ria driveshaft l360 would contribute to the complained device issue.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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -drive shaft assembly (b)(4) (manufactured and manufactured).-sleeve, ria 3(current and manufactured).Dimensional inspection: n/a 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 DRIVESHAFT L360
• 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: 16645122
• Report Number: 8030965-2023-03876
• Device Sequence Number: 6061115
• Product Code: HTO
• UDI-Device Identifier: 07611819739192
• UDI-Public: (01)07611819739192
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: 314.742
• Device Lot Number: H730294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIA DRIVESHAFT L520; RIA REAMER HEAD Ø12; RIA REAMER HEAD Ø13
• Patient Age: 19 YR
• Patient Sex: Male