MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Model Number	294.56
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.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.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 (b)(6) 2018 the patient underwent removal of a broken 5.0mm schanz screw.At the same time the patient also was implanted with a plate and screws on the same date.The plate and screws were synthes devices and intact.The patient originally had an external fixator performed on (b)(6).As a medical intervention the surgeon removed the broken schanz screw, and just left the plate and screws in the patient.It was unknown if there were any surgical delays and if there were fragments generated from the broken device.The procedure and patient outcome were unknown.Concomitant device: plate (part unknown, lot unknown, quantity 1), screw (part unknown, lot unknown, quantity unknown) this report is for one (1) 5.0mm schanz screw.This is report 1 of 1 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.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.
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.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 a removal of a broken schanz screw blunter trocar point.The patient originally had an unknown external fixator performed on (b)(6).As a medical intervention, the surgeon removed the broken schanz screw, and implanted an intact unknown plate and unknown screws in the patient.There was a five (5) minutes surgical delay reported.The procedure and patient outcome were unknown.This report addresses the hardware removal procedure due to postoperative broken schanz screw.The intraoperative issues that occurred during removal procedure have been captured under related complaint (b)(4).Concomitant device: unknown plate (part # unknown, lot # unknown, quantity 1); unknown screws ( part # unknown, lot# unknown, quantity unknown).

• Brand Name: 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM
• Common Device Name: APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8026431
• Report Number: 2939274-2018-54725
• Device Sequence Number: 1755539
• Product Code: LXT
• UDI-Device Identifier: 10886982181572
• UDI-Public: (01)10886982181572
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2018

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: 294.56
• Device Catalogue Number: 294.56
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 11/30/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/29/2018; 11/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100