MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.9MM LOCKING BOLT 50MM; PIN, FIXATION, THREADED

Catalog Number 259.500

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.(b)(6) 2016 was reported as the date of event but is unknown if this is the date the patient¿s pain symptoms began or if this was the date the patient returned to the surgeon and the nail breakage and nonunion were discovered.The exact date the nail broke is unknown but occurred approximately five (5) months after initial implantation.Additional product code: jds.(b)(6).Manufacturing site: (b)(4).Manufacturing date: june 30, 2010.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.A manufacturing evaluation was completed: part received in a minigrip.The etching is illegible since the surface of the head is ruined so it is no possible to verify if the lot number is correct.The screw is visibly bent.The raw material certificate has been reviewed.In the certificate it is reported that the material is consistent with the order requirements.The returned screw was re-inspected for all the features pertinent to the complaint condition.The measure where taken in the area close to the screw head since it is undamaged.The thread profile was found conforming to specifications.The length of the screw was not measurable since the screw is bent, however through the screw length and the thread profile it was possible to identify the article and confirm that the geometry correspond to part 259.500.No evidence of defects manufacturing related noticed.The part was damaged post production.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.No manufacturing related issue was identified.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

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that revision surgery was performed on (b)(6) 2016 due to a broken nail, patient pain and nonunion.The patient was initially implanted with the reported nail and two 4.9mm locking bolts on (b)(6) 2016.On approximately (b)(6) 2016, the patient returned to the surgeon reporting severe pain.Examination revealed the nail was broken at the distal locking hole and there was nonunion of the fracture.The patient denied any trauma which might have resulted in the device breakage.The devices were explanted and the revision surgery was successfully completed.When the product was received by the manufacturer, it was noted that the previously reported concomitant locking bolt (part 259.500, lot 3486153) was bent.Updated concomitant devices: 4.9mm locking bolt 38mm (part 259.380, lot 3486141, quantity 1) this is report 2 of 2 for com-(b)(4).

Manufacturer Narrative

A product investigation for the returned concomitant device was completed: the bolt is in good condition, based on this and that this bolt do not had an influence to the breakage of the nail.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: 4.9MM LOCKING BOLT 50MM
• Type of Device: PIN, FIXATION, THREADED
• 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: 6219636
• MDR Text Key: 63765981
• Report Number: 1000562954-2017-10000
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819010420
• UDI-Public: (01)07611819010420(10)3486153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970097
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259.500
• Device Lot Number: 3486153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 PART 259.380, LOT 3486141, 4.9MM LOCKING BOLT
• Patient Outcome(s): Required Intervention
• Patient Weight: 67