MAUDE Adverse Event Report: SYNTHES GMBH 17.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.030S

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

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Additional procode: hto.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 the patient underwent surgery using the ria 2 on the right proximal femur to have bone and bone marrow harvested.The procedure was successfully completed.On (b)(6) 2020 the patient was hospitalized again with a right femur fracture at the grafting site.The right femur was treated with femoral nail and cerclage from another company on (b)(6) 2020.There was patient consequence.There is no further information available.Concomitant devices reported: unknown nail (part# unknown, lot# unknown, quantity 1).Unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) 17.0mm reamer head for ria 2 sterile.This is report 2 of 3 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, h4, h6- the fracture of the femur can be confirmed on the received x-rays.If this occurrence is in any relation to the ria 2 reamer system cannot be confirmed based on these post-operative pictures (female_1958.Pdf), therefore the complaint is rated as n/a in the confirmed field.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 history lot : part # 03.404.030s, synthes lot # 57p0545, supplier lot # na, release to warehouse date: 19 may 2020, expiration date: 01 may 2030 , manufactured by synthes jabil, no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: 17.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10816301
• MDR Text Key: 217438191
• Report Number: 8030965-2020-08759
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142528
• UDI-Public: (01)07612334142528
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.030S
• Device Lot Number: 57P0545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REAMER HEAD F/RIA 2 Ø16; RIA 2 BONE HARVESTING KIT L520; UNK - NAILS; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention