MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM; SCREW, FIXATION, BONE

Model Number	202.888
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Additional device product code: hrs.Device is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 (b)(6) 2018 during shipment from (b)(6) four (4) cortex screw self tapping with t8 stardrive recess was found to be bent beyond use.It was also noted that the box was damaged.There were no patient and procedure involvement.This is report 1 of 4 for complaint (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.Initial reporter is synthes sales consultant.A review of the device history records has been requested.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 five (5) cortex screw self-tapping with t8 stardrive recess were received damaged on (b)(6) 2018.The devices were found to be bent beyond use.It was also noted that the shipping box was damaged.No patient or surgical involvement.This report is for one (1) 2.7mm cortex screw.This is report 1 of 5 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: manufacturing location: monument , manufacturing date: 09-apr-2018 , part number: 202.888, 2.7mm cortex screw slf-tpng with t8 stardrive recess 28mm, lot number: h613012 , lot quantity: 239.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect mill threads, flute / final inspection met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and found to be conforming.Packaging bom was reviewed and all materials used for packaging met current documented requirements.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device condition: device was not returned.Visual inspection of the provided photo attached to the complaint file titled "(b)(4) photos image1.Pdf" identified a bent screw, which agrees with the reported complaint condition.Only a portion of the poly bag with bent screw is visible because other screw packages are obstructing the full view of the package.The visible portion of the bag appears to have minor post manufacturing damage.In the top left of the bag, the distal third of the screw appears bent at an approximate angle of 20 - 30 degrees.The visually inspected condition of the provided photo agrees with the reported condition and therefore this complaint is confirmed.Document/specification review: a relevant design drawing review was not performed during this investigation as the post manufacturing damage to the screw, screw poly bag and outer carton are determined to be due to rough handling during transport.Dimensional analysis: a relevant dimensional analysis was not able to be performed because the complaint device was not returned.Conclusion: the post manufacturing damage to the screw, screw poly bag and outer carton are determined to be due to rough handling during transport.The overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.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.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 CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM
• 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: 7810416
• Report Number: 2939274-2018-53442
• Device Sequence Number: 19348260
• Product Code: HWC
• UDI-Device Identifier: 10886982145130
• UDI-Public: (01)10886982145130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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,Followup,Followup
• Report Date (Section B): 07/25/2018

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: 202.888
• Device Catalogue Number: 202.888
• Device Lot Number: H613012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 09/14/2018; 10/24/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/14/2018; 10/25/2018
• Patient Sequence Number: 1