MAUDE Adverse Event Report: SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION, APPARATUS, NON-POWERED

Catalog Number 357.371

Device Problems Sticking (1597); Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

Additional patient information: patient height reported as (b)(6).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: supplier: (b)(4) / packaged by: (b)(4) ¿ manufacturing date: july 27, 2011.No non-conformance reports were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device 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

It was reported that a buttress compression nut became bounded on the threaded blade guide sleeve during a surgical procedure on (b)(6) 2016.The encountered issue prevented further advancement of the nut.A replacement device was used to complete the procedure, which was prolonged by approximately twenty-five (25) minutes.The procedure was completed without further incident.Concomitant device(s) reported: aiming arm (part: 357.366 / lot: 7521881, quantity: 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: three devices were received for investigation.The devices cosmetically damaged in the form of scratches and wear consistent with use and sterilization.The devices individually appear to be functioning properly.The devices were assembled together and each one functioned properly without any issues.The buttress compression nut did not bind and was able to be fully threaded onto the blade guide sleeve without any issues.The cause of the issue is unknown.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is unconfirmed.The relevant drawings were reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A functional/visual test was performed and no issues were found.No issues were found with any of the returned devices.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: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION, APPARATUS, NON-POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5781237
• MDR Text Key: 49127931
• Report Number: 1719045-2016-10537
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Device Lot Number: 6647902
• Other Device ID Number: (01)10886982196057(10)6647902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60