MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 Ø10

Catalog Number 03.404.016S

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrx complainant part is not expected to be returned for manufacturer review/investigation.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) 2021 during a tibial nailing case, surgeon initially tried to ream with the synream system, but canal was very tight and struggled to get down with the 8.5mm reamer head.Unable to pass, surgeon requested reamer irrigator aspirator (ria) 2 system.Ria 2 flexible reaming shaft and 10mm reamer head used, without the single use outer plastic sheath or irrigation.During first pass with reamer, the tangs snapped off from the reamer head.The tangs were retained inside the reaming shaft, but the reaming head was left in the canal of the bone.The broken head was removed using the in situ, ball tipped guidewire.They proceeded to open a 10.5mm reamer head and completed the case with no adverse events.There was a surgical delay of fifteen (15) minutes, as they needed to retrieve the reamer head from the canal using the ball tipped rod.There was no harm to the patient.This report is for one (1) 10.0mm reamer head for ria 2 sterile this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image provided.The image was reviewed, and the complaint condition can be confirmed.The tangs of the reamer head are broken off.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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 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 review: there is no known lot number, therefore a manufacturing record evaluation cannot be completed.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: REAMER HEAD F/RIA 2 Ø10
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; wien 1020 ; AU 1020
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12769930
• MDR Text Key: 284623989
• Report Number: 8030965-2021-09342
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334142382
• UDI-Public: (01)07612334142382
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0571-2021
• Patient Sequence Number: 1
• Treatment: UNK - FLEXIBLE SHAFTS.