MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/10MM; SCREW, FIXATION, BONE

Model Number	02.118.510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the screw broke.Additional procode: hrs.Lot number is unknown.Device malfunctioned intra-operatively and it is unknown if the screw was implanted.It is unknown if or when device was 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 during an unknown procedure on an unknown date, the head of a metaphyseal screw broke off while being tightened.It was unknown if there was any surgical delay or if the surgery was successfully completed.There is no reported patient consequence.This report is for a 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/10mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2018 due to a tibular fracture, the head of a (1) metaphyseal screw broke off while tightening.The metaphyseal screw was retained inside the patient.No intervention was done to remove the broken metaphyseal screw.There was no surgical delay and surgery was successfully completed.Patient was stable.
Additional 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.Device was not explanted.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.Initial reporter information provided 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: 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/10MM
• 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: 7597515
• Report Number: 2939274-2018-52496
• Device Sequence Number: 19129539
• Product Code: HWC
• UDI-Device Identifier: 10886982039163
• UDI-Public: (01)10886982039163
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 02.118.510
• Device Catalogue Number: 02.118.510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1