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

Catalog Number 357.371

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record was completed: troutman industries manufactured the buttress / compression nut for 357.399.The certificate of compliance indicates the lot was made to the synthes drawing and manufactured per material requirements and specifications.The lot was inspected and conformed to the synthes incoming final inspection sheet.There were no complaint-related anomalies, material review reports, or non-conformance reports associated with this lot.The parts were released to the warehouse on (b)(4) 2011.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

It was discovered in sterile processing on (b)(6) 2015 that the aiming arm, buttress compression nut and blade guide sleeve were sticking together when assembled/disassembled.This event did not involve a patient.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

The devices were discovered in a non-working condition on (b)(6) 2015.However, it is unknown when the issue initially/originally occurred.Product investigation summary: the returned aiming arm (part 357.366 / lot 7979724), blade guide sleeve (part 357.369 / lot 6702210), and buttress/compression nut (part 357.371 / lot 6722770) show some wear, but are in working condition with no defects that would impair their function.The devices function as designed.A visual inspection, dimensional inspection, drawing review, and device history record review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The devices were reported to be sticking together upon assembly and disassembly in sterile processing.This complaint is unconfirmed.The complaint condition cannot be replicated.The device assembles and disassembles without sticking or any other difficulty.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.There were no issues found with the returned device; therefore, a corrective action is not warranted.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.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5064394
• MDR Text Key: 25300512
• Report Number: 1719045-2015-10583
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• 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: 6722770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2011
• 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