MAUDE Adverse Event Report: SYNTHES (USA) GRAPHIC CASE FOR LCP® PERIPROSTHETIC SYSTEM; TRAY, SURGICAL INSTRUMENT

Catalog Number 690.413

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process.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 during inspection of a locking compression plate (lcp) periprosthetic systems set on (b)(6) 2016, it was noticed that the screw caddy was damaged.One of the screws to the lid was not in place, it wasn't screwed into the lid and several 5.0mm periprosthetic locking screws were found at the bottom level of the graphic case.All screws were retrieved except for one missing 5.0mm periprosthetic locking screw.The set was not used in surgery and there was no patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: one graphic case (part 690.413, lot unknown) and its associated inserts and trays were received for investigation.The graphic case is severely worn with wear and fading evident on most surfaces as well as the trays/inserts.The nylon coating on various inserts has worn off in a few locations.One screw is missing from the lid of the internal screw caddy (part 690_413_40).The lid of the caddy does not properly latch.The root cause for the lost screw is unknown, but due to the condition of the cause, wear from use and sterilization is likely a contributing factor.Upon inspection, it was found that the device was missing subcomponent part 690_413_43.This causes the lid of the screw module to not properly latch, thereby allowing the screws to unintentionally come out.The relevant drawing for the device(s) was 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 was unable to be performed since the lot number is unknown.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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: GRAPHIC CASE FOR LCP® PERIPROSTHETIC SYSTEM
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5736470
• MDR Text Key: 47792538
• Report Number: 2520274-2016-13215
• Device Sequence Number: 1
• Product Code: FSM
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 690.413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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