MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 18MM; SCREW, FIXATION, BONE

Model Number	02.210.118
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: 19-dec-2020.Part number: 02.210.118, 2.4mm va locking screw stardrive 18mm lot number: 83p2364 (non-sterile) lot quantity: (b)(4) two pieces were scrapped in cell, mill shaft thread/head, as tooling set-up scrap.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, mill shaft threads, head threads & flutes, final inspection met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.(b)(4).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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of two packages received unsealed along the edge with no product inside does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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) 2020 the two (2) 2.4mm va locking screw stardrive packages were unsealed along the edge and there were no products in the package.There was no patient involvement.This report is for one (1) 2.4mm va locking screw stardrive 18mm.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 18MM
• 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: 11202411
• Report Number: 2939274-2021-00387
• Device Sequence Number: 16740422
• Product Code: HWC
• UDI-Device Identifier: 10886982052957
• UDI-Public: 10886982052957
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: 02.210.118
• Device Catalogue Number: 02.210.118
• Device Lot Number: 83P2364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/20/2021
• Patient Sequence Number: 1