MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of symptom onset is unknown.This report is for three (3) unknown locking screws.Without a valid part and lot number, the udi is not available.The original implant procedure was performed on an unknown date approximately ten (10) years ago.Theses three (3) locking screws were intentionally left in situ.The devices are not expected to be returned for manufacturing review/investigation.Pma: unknown, as specific part and lot numbers for the complainant screws were not provided.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that a patient was originally treated for an edentulous mandible fracture on an unknown date approximately ten (10) years ago.At an unknown time, the patient returned to the surgeon complaining of pain and swelling.A fistula infection was confirmed and initially treated with antibiotics.Despite treatment, the patient returned again, on a later date, still reporting pain.On (b)(6) 2016, the patient underwent a revision procedure during which the wound was debrided and cleaned.In the area of infection, a portion of the 2.4mm angle-to-angle locking plate was cut and removed along with two (2) 2.4mm locking screws.The other portion of the plate and three (3) locking screws were intentionally left in the patient.No fragments were generated during removal.The fracture itself had reportedly healed with no evidence of non-union, mal-union, or re-fracture.The procedure was completed successfully with no known surgical delay or additional medical intervention.This report is for three (3) unknown locking screws.This report is 3 of 3 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5689047
• MDR Text Key: 46218823
• Report Number: 2520274-2016-12929
• Device Sequence Number: 1
• Product Code: HWC
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention