MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPEEDSHIFT COMPRESSION IMPLANT KIT 20X20X20MM OFFSET 10MM; STAPLE, FIXATION, BONE

Model Number SE-2020-10

Device Problem Mechanical Jam (2983)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device remained successfully implanted in patient.Complainant part is not expected to be returned for manufacturer review/investigation.Physical product investigation could not be completed; no conclusion could be drawn, as no product was received.(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 the product that would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture 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.

Event Description

It was reported that while performing a foot procedure on (b)(6) 2017, as the surgeon was placing the first staple implant, the staple did not release or separate from the insertion tool.With some difficulty, the surgeon was able to insert the first staple in the pre-drilled hole successfully.The surgeon then proceeded to insert the second staple implant and it would also not release or separate from the insertion tool.Due to additional complexity, the staple was inserted in a different hole which was created as the staple inserted itself.This procedure was completed successfully with a 3 minute surgical delay.The patient is reported to be in stable condition.Concomitant device reported: unknown insertion tool (part number unknown, lot number unknown, quantity 1).This complaint is for two (2) devices.This report is for the first staple implant to be inserted during the surgical procedure; (b)(4).

Manufacturer Narrative

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: SPEEDSHIFT COMPRESSION IMPLANT KIT 20X20X20MM OFFSET 10MM
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7148862
• MDR Text Key: 96127712
• Report Number: 2939274-2017-50451
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: SE-2020-10
• Device Catalogue Number: SE-2020-10
• Device Lot Number: BSE160307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR