MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW FULLY THREADED/46MM; SCREW, FIXATION, BONE

Model Number	214.746
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The device was 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 during an unknown surgical procedure on an unknown date, the tip of the cannulated screw threads broke off during insertion into the bone.This report is for one (1) 4.5mm 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary.Visual inspection: visual inspection of the returned device performed at customer quality confirmed the condition of screw breakage, which agrees with the reported complaint condition.One of the three distal cutting tips has broken off and was not returned.No other damage was observed.Dhr review: no device history record review could be performed as the lot number was not provided and a lot number etching does not exist on the returned screw.Document/specification review: no product design issues or discrepancies were observed during this investigation.Dimensional inspection: the inside diameter of the returned screw measured 1.76mm which is within specification of 1.75mm +0.1/-0.0mm.The external major thread diameter of the returned screw measured 4.42mm which is within specification of 4.5mm +0/-0.15mm.The external minor thread diameter of the returned screw measured 2.70mm which is within specification of 2.7mm +/-0.05mm.Material analysis: a material certification from the time of manufacture could not be reviewed because no device history record (dhr) review could be performed.Conclusion: a definitive root cause for the screw tip breaking intraoperatively could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new, unique or different patient harms were identified as a result of this evaluation.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: 4.5MM CANNULATED SCREW FULLY THREADED/46MM
• 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: 8066206
• Report Number: 2939274-2018-54957
• Device Sequence Number: 16679586
• Product Code: HWC
• UDI-Device Identifier: 10886982154446
• UDI-Public: (01)10886982154446
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 214.746
• Device Catalogue Number: 214.746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1