MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, NAIL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 3.5mm locking screw/unknown lot.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that a revision of a left proximal humerus was performed due to a non-union and broken 3.5mm locking screw.The patient was revised to another 3.5mm locking compression plate (lcp) proximal humerus plate.There was no delay in surgery or patient harm reported.There was an intra-operative event during the revision procedure which is being captured under linked compliant (b)(4).Concomitant devices reported: 3.5mm lcp proximal humerus plate (part 241.901, lot 9841171, quantity 1); cortex screw (part 204.8xx, lot unknown, quantity 3); locking screw (part 212.1xx, lot unknown, quantity 4).This report is for an unknown 3.5mm locking screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6148756
• MDR Text Key: 61541156
• Report Number: 2520274-2016-15596
• Device Sequence Number: 1
• Product Code: JDS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• 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
• Treatment: 1 PART 241.901, LOT 9841171,PROXIMAL HUMERUS PLATE; 3 PART 204.8XX, LOT UNKNOWN, CORTEX SCREWS; 4 PART 212.1XX, LOT UNKNOWN, LOCKING SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 80