MAUDE Adverse Event Report: WRIGHTS LANE:SYNTHES USA PRODUCTS LLC; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event is unknown.Pma/510k: four unknown screws: locking /unknown lot.Part and lot number are unknown; udi number is unknown.Implant date unknown¿approximately 2 weeks prior to (b)(6) 2017.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 manufacture date is unknown.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 the patient underwent revision of a 7 hole 4.5mm locking compression plate (lcp) narrow plate and six screws on (b)(6) 2017 due to pain and three screws backing out of the bone.The plate along with two (2) cortex screws and four (4) locking screws were originally implanted during an open reduction internal fixation (orif) humerus nonunion approximately two (2) to three (3) weeks ago.The patient was complaining of pain and it was discovered by x-ray during a follow-up visit on november 15, 2017 that one cortex and two locking screws backed out of the bone.All devices were removed and replaced with a longer 4.5 lcp plate and screws.The procedure was successfully completed with no delay.The patient outcome was as expected.Concomitant devices reported: 4.5 mm 7 hole lcp narrow plate (part # 224.571, lot # unknown, quantity # 1); locking screws (part # unknown, lot # unknown, quantity # 2); cortex screw (part # unknown, lot # unknown, quantity # 1).This report is for 4 unknown screws: locking.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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): WRIGHTS LANE:SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7113741
• MDR Text Key: 94731602
• Report Number: 2939274-2017-50258
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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
• Date Manufacturer Received: 01/08/2018
• 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