MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.016S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

Additional procode: hto.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during surgery, the surgeon was performing a procedure involving inserting a humeral nail into a right humerus due to a cancerous growth development in the bone.The bone was to be pre-reamed for nail insertion to add strength to the bone to prevent fracture.The surgeon planned to use th eria 2 system to ream for the 9mm nail and collect tissue sample for histology findings.When using the 10mm diameter ria2 system, the cutting head snapped off from the drive shaft of the instrument making it unusable.The surgeon instead used a 7mm diameter nail than expected resulting in less strength.There was a surgical delay of twenty (20) minutes.Fragments were generated and easily removed without additional intervention.The procedure was successfully completed.The patient outcome is unknown.Concomitant devices reported: unknown drive shaft (part# unknown, lot# unknown, quantity# 1), unknown humeral nail (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

Event Description

It was further reported that the surgeon used the 2.5mmx950mm guide wire during procedure, which prevented the 10mm reaming head from being lost in the patient¿s humeral inter medullary canal.The surgeon also followed all instructions to use the product, the power tool was on the correct setting, his force wasn¿t forcefully, he advanced and retracted the device periodically to allow the framing a to be emulsified, the product was also inserted at a neutral angle.Updated concomitant devices reported: drive shaft (part# unknown, lot# unknown, quantity# 1), humeral nail (part# unknown, lot# unknown, quantity# 1), synream reaming rod ø2.5 short l950 (part# 352.032s, lot# unknown, quantity# 1).

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.H6: picture review: on the received picture there is a broken cutting head of a ria2 visible.Therefore, the complaint is rated as confirmed.The review of the picture does not allow to any determination of any root cause.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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 h4, h6: a device history record (dhr) review was conducted: part # 03.404.016s, synthes lot # 37p6516, supplier lot # na, release to warehouse date: 25 jan 2020, manufactured by jabil monument, expiration date: 01 jan 2030.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: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10623481
• MDR Text Key: 209772375
• Report Number: 8030965-2020-07688
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142382
• UDI-Public: (01)07612334142382
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 37P6516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNREAM REAMING ROD Ø2.5 SHORT L950; UNK - NAILS: HUMERAL; UNK - NAILS: HUMERAL; UNK : DRIVE SHAFT; UNK : DRIVE SHAFT
• Patient Age: 41 YR