MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RIA; REAMER

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown reamer/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a debridement procedure for a suspected infected tissue within the left femur was performed.The surgeon completed the irrigation and then placed the ria ii over the reaming rod through the canal.The surgeon inserted a 2.5mm reaming rod down the intramedullary canal of the femur using the entry point of the nail that was taken out.It was then discovered that there was a deformation of the seal within the tube assembly.The surgeon inspected the ria to see if the seal could be replaced.The tube assembly was damaged, so the surgeon decided to use another product (canal brush) to complete the procedure.The procedure had a surgical delay of ten (10) minutes.The procedure was successfully completed.Concomitant device reported: 2.5mm synream reaming rod (part # 352.032s, lot # 6l09268, quantity unknown), reamer head for ria 2 (part # 03.404.016s lot # 38p2161, quantity unknown), unknown stryker power tool (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown ria reamer.This is report 2 of 2 for (b)(4).(b)(4) will capture the intra-op event where the ria 2 bone harvesting kit and the unknown ria drive shaft encountered an issue during the debridement procedure, while (b)(4) will capture the post-op event where the patient underwent removal of the unknown 12mm intramedullary nail due to pain from suspected infection.

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.Complaint is confirmed as we are able to confirm complaint description (unable to disassemble) based on the received pictures.Product was not returned therefore no further investigation possible.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 (information or/and material), 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.

• Brand Name: UNK - RIA
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10635805
• MDR Text Key: 210220240
• Report Number: 8030965-2020-07741
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• 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: 10/19/2020
• Patient Sequence Number: 1
• Treatment: REAMER HEAD F/RIA 2 Ø10; RIA 2 BONE HARVESTING KIT L520; SYNREAM REAMING ROD Ø2.5 SHORT L950; UNK - STRYKER POWER TOOL
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR