MAUDE Adverse Event Report: SYNTHES GMBH RIA REAMER HEAD Ø14.5; MEDULLARY CANAL ORTHOPAEDIC REAMER, FLEXIBLE

Catalog Number 352.255S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Septic Shock (2068)

Event Date 05/16/2022

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 6 for (b)(4).It was reported by the physician in (b)(6) that immediately after using ria system for the femur, the patient became unconscious then resuscitated and became fine afterwards.According to the report, the patient had septic shock when the surgeon was about to suture.It was further reported that the septic shock had nothing to do with the ria system that was used during surgery.It was reported that the reaming and irrigation with the ria was done and the procedure was completed.There were no surgical delay reported.The status of the patient was unknown.No additional information was provided.This complaint involves six (6) devices.

Manufacturer Narrative

Additional narrative: 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.Complainant part is not expected to be returned for manufacturer review/investigation.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.Investigation summary: 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 history lot: part: 352.255s lot: 8l53486: a manufacturing record evaluation was performed for the finished lot and no non-conformances were identified.

Event Description

Patient outcome is reported as okay.

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.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 REAMER HEAD Ø14.5
• Type of Device: MEDULLARY CANAL ORTHOPAEDIC REAMER, FLEXIBLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14758389
• MDR Text Key: 295032668
• Report Number: 8030965-2022-04202
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K013527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 352.255S
• Device Lot Number: 8L53486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male