MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Catalog Number 03.404.035

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

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) 2020 that the bone was measured at around 12mm at the ishamus.A 13mm reamer head size was chosen.The ria 2 was put together as per the surgical technique.The im canal was opened with an opening reamer from the ria 2 set and the 2.5mm guide wire was put down the left femur.The ria 2 system was used on drill speed as per the surgical technique.It was noted that the patient had harder bone than expected.The reamer reached the end of the femur and some metal shards were identified.The ria 2 system was removed and an attempt was made to remove the metal shafts using an endoscopic grasper.This was unsuccessful.Concomitant devices reported: guide wire (part # 357.399s, lot # 6l64784, quantity # 2); synream reaming rod (part # 352.032s, lot #7l07367 , quantity # 1); variable angle medial distal tibia plate (part # 02.118.007s, lot # l356385 , quantity # 1).This report is for one (1) drive shaft for ria 2 520mm.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: investigation summary: background: ria 2 case - bone was measured at around 12mm at the ishamus.A 13mm reamer head size was chosen.Ria 2 was put together as per the surgical technique from what was witnessed.Surgeon (raj shetty) opened the im canal with an opening reamer from the ria 2 set and put the 2.5mm guide wire down the left femur.From there the ria 2 system was used on drill speed as per the surgical tech.It was noted that the patient had harder bone than expected.Reamer reached the end of the femur and some metal shards were identified.Ria 2 system was removed and an attempt was made to remove the metal shafts using an endoscopic grasper.This was unsuccessful.Reamer head and shaft/tube are available to be sent back.09/30/2020: concomitant devices reported: guide wire (part # 357.399s, lot # 6l64784, quantity # 2), synream reaming rod (part # 352.032s, lot #7l07367 , quantity # 1), variable angle medial distal tibia plate (part # 02.118.007s, lot # l356385 , quantity # 1).Not: the following investigation is based on the device received and pictures attached.Investigation flow: damage/ functional.Visual inspection: drive shaft f/ria 2 l520 (part# 03.404.035, lot# unknown, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device was stuck inside the ria 2 harvesting kit.But no broken features were observed with the device.Device failure/ defect was identified.Functional inspection: during functional test, an attempt to disassemble the drive shaft from the ria device was failed.But the drive shaft was able to rotate freely.Further functional test cannot be performed due to stuck condition of the device.The complaint unable to perform or replicated with the returned device.Dimensional inspection: dimensional inspection of the received device was not performed as the relevant features of the device are inaccessible due to the stuck condition.Document/ specification review: drawings were reviewed during the investigation: no design issues or discrepancies were noted during the investigation.Complaint not confirmed.No broken features were observed with the device.Investigation conclusion: the complaint could not be confirmed for drive shaft f/ria 2 l520 (part# 03.404.035, lot# unknown) as no broken features were observed with the device.A definitive root cause cannot be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.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: DRIVE SHAFT FOR RIA 2 520MM
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10693067
• MDR Text Key: 211869523
• Report Number: 8030965-2020-08026
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334143037
• UDI-Public: 07612334143037
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT F/RIA 2 L520; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; REAMER HEAD F/RIA 2 Ø13; RIA 2 BONE HARVESTING KIT L520; SYNREAM REAMING ROD Ø2.5 SHORT L950; SYNREAM REAMING ROD Ø2.5 SHORT L950; VA-LCP MED DIST TIB PL 2.7/3.5 LE 8HO L1; VA-LCP MED DIST TIB PL 2.7/3.5 LE 8HO L1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR