MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 42MM; SCREW, FIXATION, BONE

Model Number 204.842

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 5¿3¿.Additional product codes: hrs, jds.Date of implant is not known.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.(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 Description

It was reported that the patient underwent removal of two (2) stainless self-tapping cortex screws on (b)(6) 2018.The removal was due to loosening of screws.It was unknown if there was a surgical delay.Patient outcome was unknown.Initial date of implant is not known.This report is for one (1) 3.5mm cortex screw 42mm.This is report 1 of 2 for (b)(4).

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.Corrected data: date of event must be unknown since complaint is against loosening of implanted screws leading to subsequent removal, and date of loosening is unknown.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.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 42MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7671192
• MDR Text Key: 113464095
• Report Number: 2939274-2018-52745
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982146397
• UDI-Public: (01)10886982146397
• Combination Product (y/n): N
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204.842
• Device Catalogue Number: 204.842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 88