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

Catalog Number 357.371

Device Problem Sticking (1597)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2014

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records was conducted.The report indicates that the: ef precision manufactured the buttress/compression nut, part #357.371, and lot #4546698 on po #354654 for (b)(4) pieces dated may 9, 2003 and processed on work order #(b)(4).Initially, the part conformed the supplier¿s certificate of conformance, dated may 8, 2003 and to the synthes final inspection sheet #(b)(4).The product was released to the warehouse on may 15, 2003.There were no mrr¿s, ncr¿s, or complaint related issues with this lot.(b)(4).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 by that a triple trochanter for the helical blade would not thread.The threads looked as if they were either dropped or hit on something.The compression nut was unable to go down due to this.The compression nut was eventually forced down.There was a 5 to 10 minute surgical delay.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The visual inspection of the returned device performed as part of the product investigation reported the buttress/compression nut was received intact.The device shows heavy wear with several scratches and nicks consistent with eleven years of use.The device was manufactured in 5/2003 and is over 11 years old.The 357.369 blade guide sleeve and 357.371 buttress/compression nut are instruments routinely used in the titanium trochanteric fixation nail system (technique guide j3900-i).The returned 357.371 buttress/compression nut shows heavy wear with several scratches and nicks consistent with eleven years of use.Drawing number 357.371 rev.B was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No product issue was identified in the complaint description or noted upon examination.Therefore, a review of the risk assessment is not applicable for this device.The returned 357.369 blade guide sleeve shows fairly heavy wear with numerous deformed threads and several scratches and hammer marks.The device was returned and reported to have deformed threads preventing the buttress/compression nut from advancing down the sleeve.This condition is confirmed; approximately two thirds of the way down the length of the sleeve the buttress/compression nut tightens and will no longer advance.It is likely that either the device was dropped or handled roughly during sterilization or that the threads may have been struck with a hammer deforming threads and rendering the sleeve unusable.Drawing number 357_369 rev.C was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.It is likely that user error has led to deformed threads on the 357.369 blade guide sleeve leading to this confirmed complaint, however this complaint is not a result of any design related deficiency.No product issue was identified in the complaint or noted upon examination of the returned 357.371 buttress/compression nut.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).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: APPARATUS, TRACTION, NON-POWERED ORTHOPEDIC TRACTION AND ACCESSORIES
• 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: 4260910
• MDR Text Key: 21850095
• Report Number: 1719045-2014-10610
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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: 4546698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2003
• 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: 78 YR