MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a cancellous bone screw synapse did not fit on the screwdriver.Procedure and patient involvement are unknown.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 3.5mm ti cancellous polyaxial screw 16mm.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.A device history record (dhr) review was conducted: part number: 04.614.016.Lot number: h679441.Date of manufacture: 29-jun-2018.Place of manufacture: brandywine.Part expiration date: none.List of nonconformances: none description of dhr review: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.A product investigation was conducted.Visual inspection: upon visual inspection, the stardrive portion of screw is stripped/rounded which will hinder the device from functioning as intended.The balance of the device shows surface wear consistent with use and which would not impact the functionality.Functional test: functional testing could not be performed with the mating screwdriver as it was not returned for evaluation.Dimensional inspection: dimensional inspection could not be performed as due to the design of the implant the stardrive recess could not assessed without damaging the implant further.Additionally the complaint was able to be visually confirmed.Document specification: the relevant documents were reviewed as part of this investigation: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: the complaint condition of is confirmed.No new issues were identified on the remaining portions of the device.Although a root cause could not be definitely determined given the unknown circumstances, it is probable that an unintended force during usage/ handling contributed to the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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.
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.H10 additional narrative: d4: lot number, d10, h4, h3, h6: the device was received, and the product evaluation is in progress.No conclusion can be drawn.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: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8287386
• Report Number: 2939274-2019-56130
• Device Sequence Number: 1448467
• Product Code: NKG
• UDI-Device Identifier: 10705034738352
• UDI-Public: (01)10705034738352
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 04.614.016
• Device Catalogue Number: 04.614.016
• Device Lot Number: H679441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/04/2019; 02/28/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/27/2019; 03/14/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.