MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 Ø13; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.022S

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the reaming head came loose from the shaft and got stuck in the shaft.The patient was informed about the fragments remained in the body and the gamma nail was inserted.Procedure was completed successfully with sixty(60) minutes of surgical delay.This report is for one (1) reamer head f/ria 2 ø13.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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, the reaming head came loose from the shaft and got stuck in the shaft.The patient was informed about the fragments remained in the body and the gamma nail was inserted.Procedure was completed successfully with sixty(60) minutes of surgical delay.This report is for one (1) reamer head f/ria 2 ø13.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.

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.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.D7a: unknown.

• Brand Name: REAMER HEAD F/RIA 2 Ø13
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13056854
• MDR Text Key: 286015092
• Report Number: 8030965-2021-10387
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142443
• UDI-Public: (01)07612334142443
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.022S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0577-2021
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT F/RIA 2 L520; RIA 2 REAMING KIT L520
• Patient Outcome(s): Required Intervention