MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.516
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.Additional procode: hsb.Lot number is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.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 (b)(6) 2018, the patient underwent hardware removal of three (3) titanium (ti) multiloc screws due to left shoulder pain.All of the screws were removed intact without any problem.The multiloc humeral nail was left in the patient.The surgeon decided to leave the nail in place as it was not sticking out nor was there a malfunction with and he felt the screws were the cause of the pain.It was not provided if there was any other medical intervention done.Procedure was completed successfully with no surgical delay.Patient outcome was not provided.Concomitant device: multiloc humeral nail (part: unknown, lot: unknown, quantity: 1).This report is for a 5.0 mm ti locking screw with t25 stardrive 26 mm for intramedullary (im) nails.This is report 3 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS
• 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: 7847559
• Report Number: 2939274-2018-53631
• Device Sequence Number: 13836821
• Product Code: HWC
• UDI-Device Identifier: 10886982085849
• UDI-Public: (01)10886982085849
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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: 04.005.516
• Device Catalogue Number: 04.005.516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/05/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR