MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Blood Loss (2597)

Event Date 10/25/2013

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown reamer-irrigator-aspirator system (ria)/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: grote, s.Et al (2015), femoral marrow cavity bone harvesting used for arthroscopic refilling of misplaced or enlarged bone tunnels in revision acl surgery, knee surgery sports traumatology arthroscopy, vol.23(3) pages 808-815 (germany).This prospective study presents a new arthroscopic technique for refilling of misplaced or enlarged acl tunnels to improve patients comfort.Between june 2012 and october 2012, a total of 5 patients (2 male and 3 female) with a mean age of 27.6 years underwent anterior cruciate ligament (acl) replacement.The reamer-irrigator-aspirator system (ria), developed by depuy/synthes (umkirch, germany), was used for antegrade bone harvesting from the ipsilateral femur.Clinical examinations were assessed during hospitalization and at outpatient visits 2 and 6 weeks as well as 6-12 months after operation.Primary operation had been conducted 21 months (range, 11-34 months) ago.Patients were included during a 6-month follow-up period.The following complications were reported as follows: 1 case of bacterial infection.1 case of acute instability after quadriceps tendon acl revision surgery.A relevant blood loss occurred due to the prolonged reaming procedure.This report is for an unknown synthes reamer-irrigator-aspirator system (ria).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.Relevant tests: provided for reporting.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.

• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8692859
• MDR Text Key: 147779216
• Report Number: 8030965-2019-65218
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention