MAUDE Adverse Event Report: SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE

Catalog Number 03.404.016S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the ria 2 was used to perform a bone graft on the right femur of the patient to use it on its left femur to compensate a large bone defect (2nd step of masquelet technique).Initially, the bone defect had been temporarily fixed with cement to enable an induced membrane.Preoperative planning was set to first use a 10 mm diameter reamer head and then a 14 mm diameter one based on the measured medullary canal at its narrower part.Another system with modified trinkle drill attachment was used.The entry point was done on the greater trochanter with the leg of the patient in good adduction so that the ria 2 drive shaft was fully and perfectly aligned with the medullary canal.A tissue protector was used to protect surrounding tissues from being damaged during the use of the ria 2.The surgeon was fully aware and cooperative with the technique doing gentle and smooth forwards and backwards movements with the reamer to prevent any failure of the system.Everything went perfectly well until the wings of the 10 mm ria 2 reamer head had broken and in the distal third of the femur.The debris was removed from inside of the intramedullary canal using different techniques (aspiration of the ria 2 and then a micro instrument used in orl and maxillo facial surgery to remove them).(3) out of (4) wings were successfully removed.One was left in place.There was a (60) minute delay but the procedure was completed.This report is for (1) 10.0mm reamer head for ria 2 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.H3, h6: a product investigation was conducted.Visual inspection: the complaint device 10.00mm ria 2 reamer head was returned to cq west chester for investigation.The reamer head had all its 4 tangs broken.One of the tangs was left embedded inside the patient and the remaining 3 were returned.This was also confirmed on the analysis of x-rays and photographs provided for investigation.The ria 2 bone harvesting kit was also received along with the complaint device and this kit had no issues relating to the complaint condition.No other issues were identified.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revisions of the drawing were reviewed: conclusion: the 10.0mm ria 2 reamer head had its distal tangs broken during surgery.There is no indication that a design or manufacturing issues or discrepancies were observed.No manufacturing issues were noted during investigation.Due to the trend with the broken ria 2 reamer heads identified during post market surveillance, the capa was raised to determine the root cause of broken head breakages.The cause of this issue was identified as deviation from the recommended surgical approach of 10 degrees.Additionally, the product issue escalation (pie) was initiated to define any further action related to the breakage.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

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.H3, h4, h6: the complaint condition can be confirmed during investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Due to the trend with the broken ria 2 reamer heads identified during post market surveillance, the capa-010231 was raised to determine the root cause of broken head breakages.Additionally, the product issue escalation (pie 1871936) was initiated to define any further action related to the breakage.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument, release to warehouse date: 22-jul-2020, expiration date: 01-jul-2030, part number: 03.404.016s, 10mm reamer head for ria 2-sterile, lot number: 62p2871 (sterile) component part(s) reviewed: part number: 03.404.M016, lot number: 6982001.Device history review : 28-jun-2021: dhr reviewed by: (b)(6).This lot met all dimensional, visual, sterility and packaging criteria 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.

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: b5.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

The breakage of the ria2 fins was systematic even for diameters much smaller than the intramedullary diameter.

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.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: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12020154
• MDR Text Key: 259186690
• Report Number: 8030965-2021-05050
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/11/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 62P2871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 06/12/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 08/12/2021; 09/13/2021; 10/15/2021
• Supplement Dates FDA Received: 07/16/2021; 09/08/2021; 10/08/2021; 10/15/2021
• Removal/Correction Number: Z-0571-2021
• Patient Sequence Number: 1
• Treatment: RIA 2 BONE HARVESTING KIT L520.; SYNREAM REAMING ROD Ø2.5 SHORT L950.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR