MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW LONG THREAD/36MM; SCREW,FIXATION,BONE

Model Number	207.736
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 or Problem Description
It was reported that on an (b)(6) 2018, the patient underwent an implantation procedure and was initially implanted with a cannulated screw, the thread came off and was thought to be encased in the bone.It was determined after the follow-up that the screw needs to be taken out.All of the metal screw was removed without issue.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.This report is for one (1) 4.0mm cannulated screw long thread/36mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW LONG THREAD/36MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8056834
• Report Number: 2939274-2018-54924
• Device Sequence Number: 16525578
• Product Code: HWC
• UDI-Device Identifier: 10886982148483
• UDI-Public: (01)10886982148483
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Health Professional
• Device Model Number: 207.736
• Device Catalogue Number: 207.736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR