MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Model Number	202.878
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id/initials and weight are unknown.Additional product code: hrs.Device broke intra-operatively and was not implanted/explanted.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.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 surgical procedure of a broken palm fracture to fix ulna with a locking compression plate (lcp).Upon insertion of the final cortex screw, the head of the screw came off.The surgeon decided to remove the entire construct to remove the screw fragment and upon an attempt to remove the next screw in the plate, the screw came off.The surgeon removed all the screws and the plate.A broken screw removal set was used to take out the screw fragment.There was a surgical delay of an hour reported to an attempt to remove the screw.The procedure was completed successfully.Patient outcome is unknown.Concomitant devices reported: screws (part 202.873, lot unknown, quantity 3), 2.7mm cortex screw, self-tapping 16mm (part 202.876, lot unknown, quantity 1), 2.7mm cortex screw, self-tapping 20mm (part 202.880, lot unknown, quantity 1), 2.0mm locking compression plate 7 holes (part 247.347, lot number unknown, quantity 1).This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• 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: 7659002
• Report Number: 2939274-2018-52701
• Device Sequence Number: 16524879
• Product Code: HWC
• UDI-Device Identifier: 10886982145086
• UDI-Public: (01)10886982145086
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 202.878
• Device Catalogue Number: 202.878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1
• Patient Age: 25 YR