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

Catalog Number 357.371

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 357.371, lot 6289832: release to warehouse date: march 26, 2010.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an (b)(6) female patient had an initial open reduction internal fixation (orif) of a right hip fracture on (b)(6) 2016.During the procedure the clip that keeps the aiming arm in place was worn and would not hold and it did not get adequate compression.The buttress compression nut that is married to the aiming arm was not holding properly.There was no patient harm and only a two minute surgical delay.The procedure was completed successfully.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product investigation summary: one (1) 130 degree aiming arm body (part 357.366 / lot 3371386) and one (1) buttress compression nut (part 357.371 / lot 6289832) were received for investigation.Both devices are extremely worn with scratches and marks in numerous locations.The aiming arm is also missing three of the four pins that affix the gold collar to the device.The devices were tested/assembled with known conforming instrumentation to test the locking mechanism of the aiming arm; no issues or discrepancies were detected.The aiming arm and compression nut functioned as intended.This complaint is unconfirmed.The exact cause for the complaint condition is unknown.A visual inspection, functional test, and drawing review were performed as part of this investigation.The current drawing for each device was reviewed.No drawing issues or discrepancies were noted.The instruments were tested with known conforming devices.The devices functioned as intended with no slippage or loss of fixation.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.No manufacturing issues were noted and no design issues were found with the current design during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5582109
• MDR Text Key: 42814430
• Report Number: 1719045-2016-10325
• 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: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6289832
• Other Device ID Number: (01)10886982196057(10)6289832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2010
• 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: 80 YR
• Patient Weight: 70