MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW LONG THREAD/50MM; SCREW,FIXATION,BONE

Catalog Number	207.750
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A review of the device history records has been requested.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 (b)(6) 2018, the patient underwent an unknown surgery.During the procedure, the surgeon inserted the cannulated screws without drilling over the k-wires.X-ray was performed, and it was found there was a metallic, wiggly, drilling piece inside the tip of the screw.The surgeon checked the k- wires that were stripped but there was no issue.They could not determine what the metallic piece was.The surgeon did not attempt to extract the metallic object due to risk of further damage to the fracture.The surgeon decided to leave it inside the patient¿s bone and complete the surgery.There was a 2-minute surgical delay.Procedure was successfully completed.The patient was reported as stable.This report is for one (1) 4.0mm cannulated screw long thread/50mm this is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative patient age provided for reporting.Patient dob provided for reporting.Device was used for treatment, not diagnosis.

• Brand Name: 4.0MM CANNULATED SCREW LONG THREAD/50MM
• 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: 8054623
• Report Number: 2939274-2018-54912
• Device Sequence Number: 11094598
• Product Code: HWC
• UDI-Device Identifier: 10886982256324
• UDI-Public: (01)10886982256324
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 207.750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 60