MAUDE Adverse Event Report: SYNTHES MEZZOVICO END-CAP F/A2FN CANN EXTENS. 5 TAN GREY; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.009.001S

Device Problem Difficult to Remove (1528)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional device product code is hwc.(b)(4).Implant date: unknown.(b)(6).For additional medical intervention due to reported event.The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number 9804670.Manufacturing location: synthes (b)(4).Date of manufacture: feb 13, 2015.Expiration date: feb 1, 2025.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during extraction surgery of an expert nail, the surgeon couldn't remove the end cap using a screw driver.The surgeon had to use a bone chisel to push out and then pull out the nail with the end cap.Extended anesthesia was needed.There was a surgical prolongation of 90 minutes reported.There is no information available about patient and surgical outcome.The hardware was initially implanted on an unknown date to treat a right femoral diaphyseal fracture.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (end-cap f/a2fn cann extens.5 tan grey, part number 04.009.001s, lot number 9347819).The subject device was returned with the complaint condition stating the upon visual inspection of the complaint implants it can be seen that the parts are blocked in each other as reported, this thus confirming the complaint description.End-cap (04.009.001s / 9347819): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in february 2015.No non-conformance reports (ncrs) were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Nail (04.009.448s / 7682325): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in december 2011.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Further investigation on the parts has shown that the end-cap is badly damaged around the screw head, as well in the recess.The nail is visible in used condition; the nail is damaged on the proximal end due to the removal attempt.Because of the damage and that the parts are blocked in each other, the complaint relevant dimensions cannot be checked for dimensional accuracy and the exact reason for this occurrence was not able to determined.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: END-CAP F/A2FN CANN EXTENS. 5 TAN GREY
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6127739
• MDR Text Key: 60902704
• Report Number: 1000562954-2016-10216
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.009.001S
• Device Lot Number: 9347819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR