MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.522S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.It is unknown when patient¿s pain began.Lot number is unknown.Date of implantation is an unknown date in 2012.Date of explantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.Reporter is a synthes sales consultant.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 or Problem Description
It was reported that on an unknown date, the patient underwent screw removal.The patient had complained of pain due to the screws rubbing against tissue.The screws were originally implanted on an unknown date in 2012.The surgical procedure was successfully completed with no surgical delay.Patient outcome is unknown.This report is for a 5.0mm titanium (ti) locking screw with t25 stardrive 32mm for intramedullary (im) nail-sterile.This is report 1 of 2 for (b)(4).
Event or Problem Description
It was further reported that during the removal procedure, screws were removed and no additional devices were implanted.
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER
• 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: 7898184
• Report Number: 2939274-2018-53903
• Device Sequence Number: 1625387
• Product Code: HWC
• UDI-Device Identifier: 10886982085917
• UDI-Public: (01)10886982085917
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.522S
• Device Catalogue Number: 04.005.522S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR