MAUDE Adverse Event Report: SYNTHES USA 4.0MM CANNULATED SCREW LONG THREAD/34MM; SCREW, FIXATION, BONE

Catalog Number 207.734

Device Problem Peeled/Delaminated (1454)

Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Other than gender, patient information not available for reporting.Date of event: unknown.This report is for unk - screw cannulated/unknown lot number.Other: udi: unknown part number, unknown lot number, udi is unavailable.Original implant date unknown.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).The 510k#: unknown.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a lisfranc surgery approximately nine months ago.Post operatively, the patient complained of uncomfortable hardware and that she could hear "clicks".One of three implanted screws was noted to be broken and the patient was revised on (b)(6) 2016.As the mid foot was stable, the surgeon elected to remove the internal fixation consisting of three 4.0mm cannulated screws, lengths unknown and a washer.The broken screw, implanted from the retrospective first metatarsal to the medial cuneiform was removed.The screw was noted to be broken at the shaft/thread junction.The threaded portion (of an unknown length) was retained in the patient's bone while the broken screw fragment was easily removed.The surgeon then began the removal of the intact screws by using a burr and inadvertently striped the first screw, making it difficult to remove.This led to a 30 minute delay in the surgery.The surgeon eventually used a broken screw removal set to explant the stripped screw, the third intact screw and an intact, unknown washer.Additional x-rays were required during the surgery when trying to remove the screws.The surgery was successfully completed with this complaint involves one (2) devices.The patient's status being stable at the end of surgery.No additional information is available.Concomitant devices reported: 4.0mm cannulated screw (part # unknown, lot # unknown, quantity 1), washer (part number unknown, lot # unknown, quantity 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date, (b)(6) 2016, was added as screw stripped during removal on this date.A product development investigation was performed for the complaint device (previously unknown screw identified as 4.0mm cannulated screw long thread/34mm, part number 207.734, lot number unknown).The complaint screw was initially received at synthes customer quality as an unknown screw with the complaint condition of ¿stripped.¿ the returned 4.0mm cannulated screw is used for fracture fixation of small bones and small bone fragments as part of the synthes cannulated screw system per the technique guide.The returned stripped screw has significant damage to the screw head recess.A visual inspection under 5x magnification was performed.The damage is consistent with use of a burr tool per the event description.The overall length of the screw is approximately 34.5mm and the thread length is approximately 11mm.Per the technique guide, for short thread screws, thread length = 1/3 screw length and for long thread screws, thread length = 1/2 screw length.Based upon measured dimensions and screw to thread length ratio, it is determined that the returned screw which has stripped hex head recess is part number 207.734.Tabulated product drawing for 4.0mm cannulated screw-long thread screw family (part #'s 207.7xx) current revision was reviewed during this evaluation.No product design issues or discrepancies were observed.A review of the device history records was unable to be performed since the lot number was unknown.The complaint condition is confirmed.A root cause was not able to be determined; however, it is not likely that the design of the device contributed to the complaint condition.The returned device was determined to be suitable for the intended use when employed and maintained as recommended.(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: 4.0MM CANNULATED SCREW LONG THREAD/34MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 5752386
• MDR Text Key: 48264502
• Report Number: 2520274-2016-13293
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 207.734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2152-2158/2016
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention