MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36MM; SCREW, FIXATION, BONE

Model Number	202.896
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, ktw.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 3 of 4 for complaint (b)(4).
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 3 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.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.
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 history record (dhr) review: part: 202.896; lot: l877405; manufacturing site: mezzovico; release to warehouse date: 03.May.2018.The device history record shows this lot of 100 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.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.Complaint condition: it was reported that on an unknown date, a shipment from fed ex was delivered with several of unknown synthes devices bent beyond use.It was also noted that the box was damaged.There was no patient and procedure involvement.Device condition: the returned screw was visually examined, and no visual damage such as device bending was observed.However, the device was not returned in any outer package carton box which could have been possibly discarded due to broken condition post transit.The device was returned only with an inner package.Furthermore, the inner package was observed with a hole at its sealing.While broken sealing on inner package doesn't definitively contribute to the reported device damage condition on the given device, the sealing issue noticed during visual analysis is also being addressed during this investigation.No new issues were identified.As no damage to device was noted and outer package was not returned, the given complaint condition was not able to be confirmed.However, with the broken sealing identified with the inner package, the overall complaint was confirmed.Dimensional analysis and document/specification review: with no visual defects identified on the device, both device drawing review and dimensional analysis was determined to be inapplicable to the given complaint condition.The device history record shows this lot of 100 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.No definitive root cause was able to be determined with the available information.However, the observed perforated sealed edge breaking on inner package could have possibly been the result of excessive loading on the screw leading to screw pushing against the sealing during package damage in transit.Conclusion: 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.Additional narrative: device manufacture date.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 36MM
• 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: 7810474
• Report Number: 2939274-2018-53445
• Device Sequence Number: 136411
• Product Code: HWC
• UDI-Device Identifier: 10886982145178
• UDI-Public: (01)10886982145178
• 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: 202.896
• Device Catalogue Number: 202.896
• Device Lot Number: L877405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 09/14/2018; 09/18/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/14/2018; 09/21/2018
• Patient Sequence Number: 1