MAUDE Adverse Event Report: SYNTHES MEZZOVICO EXPERT A2FN ¿10 LE CANN L340 TAN LIGHT GREEN, STERILE; NAIL, FIXATION, BONE

Catalog Number 04.009.349S

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon experienced difficulty when attempting to remove the end cap in question.The end cap, a nail, and one lateral locking screw were left in the patient.A surgical time delay of thirty (30) minutes was reported.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Patient identifier and weight are unknown.Device was not successfully explanted ¿ parts of the original implant remain in the patient.Parts remaining in patient ¿ failure to remove.Device is not distributed in the united states, but is similar to a product marketed in the u.S.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: april 7, 2012 - expiry date: april 1, 2022.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.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: EXPERT A2FN ¿10 LE CANN L340 TAN LIGHT GREEN, STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4584969
• MDR Text Key: 5337450
• Report Number: 1000562954-2015-10063
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 04.009.349S
• Device Lot Number: 7854638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR