MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 16MM; SCREW, FIXATION, BONE

Model Number	02.210.116
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history: manufacturing location: (b)(4), manufacturing date: 02-jan-2018, part number: 02.210.116, 2.4mm va locking screw stardrive 16mm lot number: h535531 (non-sterile), lot quantity: (b)(4).Device history review 30-jan-2019: dhr reviewed.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.Work order traveler met all inspection acceptance criteria.There was a weight variance of (b)(4) pieces detected, sputter coating.Count was verified at (b)(4) pieces, vision sort, by means of the vision system count.Inspection sheet, mill shaft threads, head threads & flutes, final inspection, met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Pll confirms the number of labels required to be 199.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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
It was reported that on (b)(6) 2019, there was a missing device from the package.It was noticed when they went to filled up the tray and when they opened up for the screw it was missing.There was no patient involvement.This complaint involves one (1) device.This report is 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.H10 additional narrative: h11: d2: additional 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.

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 16MM
• 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: 8335849
• Report Number: 2939274-2019-56429
• Device Sequence Number: 986335
• Product Code: HWC
• UDI-Device Identifier: 10886982052933
• UDI-Public: (01)10886982052933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 01/23/2019

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: 02.210.116
• Device Catalogue Number: 02.210.116
• Device Lot Number: H535531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 02/13/2019
• Patient Sequence Number: 1