MAUDE Adverse Event Report: SYNTHES (USA) 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.456E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Synthes was made aware of the event on april 1, 2015; however, synthes was not aware of this device until its receipt on sep 1, 2015.The actual date of implant may have been (b)(6), 2015.It is unknown which of the reported screws where implanted on which of the reported dates.Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process and will be addressed and reported under (b)(4).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 the patient had a follow-up visit after having a distractor implanted on (b)(6), 2015 and the subsequent implantation of 6 additional screws on (b)(6), 2015.The details of this first revision surgery are addressed and were reported under the related (b)(4).During the follow-up visit the surgeon noticed the development of a staphylococcal infection.The surgeon also noticed difficulty with the left side distractor turning and moving.The patient underwent antibiotic treatment and the surgeon planned to remove the distractor after the infection was resolved.The right side distraction was completed and has reached treatment objectives.The surgeon scheduled the hardware explant/revision surgery on (b)(6) 2015 and the hardware was removed.This complaint addresses the occurrence of infection.Conditions discovered during the explant surgery, details of the revision surgery and the subsequent patient treatment are addressed under related (b)(4).The receipt and evaluation of the complained devices will also be addressed under the related complaint (b)(4).This report is 20 of 21 for (b)(4).

• Brand Name: 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5073039
• MDR Text Key: 25621884
• Report Number: 2520274-2015-15821
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400.456E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 43