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

Catalog Number 357.371

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reported that the blade guide sleeve and buttress compression nut for the 135 degree aiming arm reportedly backed out rather than advancing.It is unknown if there was patient involvement.There is no additional information is available at this time.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: november 01, 2002.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: three devices (part 357.369, lot 4474601; part 357.371, lot 4436456; part 357.367, lot 3417225) were received for investigation.All three devices are worn with considerable scratches and marks consistent with regular use.The devices were functionally tested and no issues were found with any of the returned devices.Each device functioned as intended separately as well as when assembled together.The root cause of the complaint condition 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, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is unconfirmed.Per the technique guide, the returned devices are reusable instruments used during implantation of titanium trochanteric fixation nails.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.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.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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5595724
• MDR Text Key: 43280630
• Report Number: 2520274-2016-12198
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• 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: 4436456
• Other Device ID Number: (01)10886982196057(10)4436456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2002
• 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