MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM; SCREW, FIXATION, BONE

Model Number	04.214.111
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown but the patient was reportedly not obese.Additional product code: hrs.Due to intra-operative issues, the device was not implanted/explanted.A product investigation was completed: visual inspection observed the returned screw was stripped at its distal thread regions.No new malfunctions were identified except for minor usage wear signs that will not affect product functionality.Based on the date of manufacture the relevant drawings were reviewed.Dimensional inspection performed at the stripped region measured outside of specifications.The out of specifications are due to the post manufacture damage.Device history record (dhr) review was not able to be performed as lot number was unknown.However, upon visual inspection it was observed that the given condition could have possibly occurred due to the unintended excessive forces on the device.Therefore, no design and material issues that would contribute to complaint condition were identified.A definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that any unintended excessive forces encountered by the device during usage could have contributed given complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 the patient underwent a hand surgery on (b)(6) 2018.During insertion, two (2) titanium cortex screws broke.The surgeon chose to leave the two (2) broken screw shafts in place and more screws were then inserted.It was noted the surgeon had difficulty inserting one of the screws that was the same size as the two that broke.The bone was predrilled and reportedly the drill bit also broke.No extra surgical actions were required.There were no fragments generated from broken devices.There was no reported surgical delay.The procedure was successfully completed.Patient outcome was stable.When the device was being investigated by the manufacture, it was noted the returned screw was stripped at its distal thread regions.This is report 4 of 4 for (b)(4).

• Brand Name: 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
• 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: 7784551
• Report Number: 2939274-2018-53336
• Device Sequence Number: 16656572
• Product Code: HWC
• UDI-Device Identifier: 10886982120861
• UDI-Public: (01)10886982120861
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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
• Report Date (Section B): 06/18/2018

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 Model Number: 04.214.111
• Device Catalogue Number: 04.214.111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/15/2018
• Patient Sequence Number: 1
• Patient Age: 34 YR