MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM CANNULATED SCREW SHORT THREAD/21MM; SCREW, FIXATION, BONE

Model Number	202.621
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: htn.Occupation: reporter is synthes employee.Without a lot number the device history records review could not be completed.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported that on unknown date, during routine incoming receiving inspection at field stocking location facility the cannulated screws short thread was found to be bent.There was no known patient or hospital involvement.This report is for one (1) 3.0mm cannulated screw short thread.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The 3.0 mm cannulated screw short thread (part number 202.621, lot number unknown) was returned.Visual inspection shows that the implant is bent inward about 1/3 third of the way down from the proximal end.The balance of the device is in good condition.This is consistent with the reported complaint condition, thus confirming the complaint.Based on visual inspection and upon review of the above drawing, it was determined that the returned device was made to specification.A device history review could not be performed as the lot number is unknown.Dimensional inspection of the screw was performed: shaft diameter (threaded portion): with the thread height 0.55 mm (x2) and a surface profile of 0.1 mm.This leads to a range of 2.9 ¿3.0 mm.The shaft diameter (threaded portion) measured 2.96 mm.This is within specifications of 2.9 ¿3.0 mm the returned screw measurements were confirming to the drawing and were determined to be suitable for their intended use.Conclusion: while no definitive root cause could be determined it is possible that any unintended forces encountered by the device during usage or handling could have contributed to complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: 3.0MM CANNULATED SCREW SHORT THREAD/21MM
• 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: 8241956
• Report Number: 2939274-2019-55805
• Device Sequence Number: 16477130
• Product Code: HWC
• UDI-Device Identifier: 10886982144324
• UDI-Public: (01)10886982144324
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K962823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 202.621
• Device Catalogue Number: 202.621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1