MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCREW 16MM THREAD/90MM; SCREW, FIXATION, BONE

Model Number	208.890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was completed: the implant was not returned, and the investigation was completed based on the supplied image.The image was reviewed, and the complaint condition could be confirmed as the image showed that one of the distal tips has sheared off from the screw and is most likely embedded in the patient based on the event description.As the implant was not returned an as received, dimensional, material or drawing reviews were not completed.A manufacturing record evaluation could not be performed as the lot number is unknown.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 during a hip pinning procedure due to a femoral neck fracture on (b)(6) 2019, two little tips of the cannulated screw was broken off while the screw was being inserted into the patient.The broken pieces were not recovered and were left embedded in the patient's bone.The procedure was successfully completed with the use of another cannulated screw.There was no surgical delay reported.Patient's condition is unknown.This report is for a cannulated screw.This is report 1 of 1 for (b)(4).
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 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
Further it was reported that along with the cannulated screw a 2.8 mm guide wire was being used to direct the screw in the proper direction.Concomitant device reported: unknown 2.8mm guide wire (part # unknown, lot # unknown, quantity unknown).

• Brand Name: 7.3MM CANNULATED SCREW 16MM THREAD/90MM
• 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: 9072489
• Report Number: 2939274-2019-60608
• Device Sequence Number: 2976101
• Product Code: HWC
• UDI-Device Identifier: 10886982150011
• UDI-Public: (01)10886982150011
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• 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,Followup
• Report Date (Section B): 08/17/2019

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: 208.890
• Device Catalogue Number: 208.890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/09/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE WIRE
• Patient Age: 59 YR