MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM; SCREW, FIXATION, BONE

Model Number 04.130.211

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrs.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 Description

It was reported that on an unknown date, the double drill sleeve for 1.5 mm cortex screw/red was broken.Upon receiving new titanium variable angle modular hand set and a titanium variable angle locking screw, self tapping with star drive recess 11 mm was received with empty screw package.There was no patient involvement.This is report 2 of 2 for (b)(4).

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.E3: reporter is a synthes employee.H3, h6: part: 04.130.211.Lot: 4l72045.Manufacturing site: grenchen.Release to warehouse date: may 24, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the screw/screw packaging was not returned.Images from sales consultant were reviewed by us customer quality investigations.Two images depicted an empty package.It could not be determined from the images that the bag was sealed; therefore, a manufacturing issue was not identified.No additional issues were observed in the image provided.Conclusion: the complaint of an empty package was confirmed with photographic investigation.As the condition of the package's seal could not be evaluated from the images provided, a manufacturing issue could not be confirmed and a conclusion code of "cause not established" was selected.However, as a manufacturing issue could not be ruled out, the "manufacturing process problem identified" result code was selected.This investigation may be updated in the future if the device/package is returned.During the investigation, no unidentified product design or manufacturing issues or discrepancies were observed that may have contributed to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H11 corrected data: d8: this should have been left blank on the initial report.G3: report source is company representative only.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 Description

This report is for a 1.5mm titanium (ti) variable angle (va)-locking screw.

• Brand Name: 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8951786
• MDR Text Key: 156270588
• Report Number: 2939274-2019-60226
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982112767
• UDI-Public: (01)10886982112767
• Combination Product (y/n): N
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.130.211
• Device Catalogue Number: 04.130.211
• Device Lot Number: 4L72045
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1