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

Device Problems Material Deformation (2976); Material Distortion (2977)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not provided by reporter.This report is for unknown screw/unknown lot number not explanted as of yet.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)(6) reports an event in (b)(6) as follows: it was reported that a procedure was done for orif.Patient had fracture in the hand, surgeon push to use 1mm screw implant from compact hand module.They had variety of implants.They were unable to determine the length of the screw implant without a depth gauge.The product was a compact and 1.0/1.3 module (set of many items).No information about date of event, delay in surgery, patient condition post-surgery and adverse event to patient.(b)(6) 2015: it was reported that during the procedure on the (b)(6) october, they opened the set and the surgeon started drilling a 1mm hole for a 1.3mm screw to repair the fracture on the patient's hand.A total of 14 screws had to be implanted on the patient.During the case, there was an issue with the depth gauge that was in the kit.The depth gauge was deemed to be broken as it was not fitting the 1mm hole.There was a delay of approximately 5 minutes while a different set from a competitor was opened.A competitor's depth gauge was used to continue with the case.13 out of the 14 screws were implanted correctly.However, 1 longer screw was implanted on the far side of the bone.On assessment, the surgeon decided that this 1 screw was too long and could potentially cause tendon rupture if not revised.The surgeon will revise the patient sometime in the future, surgery date has not been set as yet.The patient was fine post procedure.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Initial reporter address, phone number: (b)(6).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.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5206762
• MDR Text Key: 30568353
• Report Number: 2520274-2015-17091
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention