MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CRTX SCR S/TAP 34MM; SCREW, FIXATION, BONE

Model Number	206.434
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
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.A device history record (dhr) review was conducted.Manufacturing location: (b)(4); release to warehouse date: 23-feb-2018.Part number: 206.434 4.0mm cortex screw self-tapping 34mm lot number: h573984 lot quantity: 239 work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label logs lppf, lmd/lpf rev b were reviewed and found to be conforming.One log was for a quantity of 236 labels used on parts, 1 label affixed to the log and 4 labels destroyed (poor print quality) for a total of 241 labels printed.The second label log was for 3 labels used on parts, 1 label affixed to the log and zero labels destroyed for a total of 4 labels printed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the production of this lot that would contribute to this complaint condition.A product investigation was conducted.The empty package was received at us cq and then sent to monument for a manufacturing evaluation.The following investigation summary was completed by manufacturing in (b)(6).Investigation summary: as received: package was returned for evaluation and examined.There is no screw inside package.Package was sealed, and no holes were visible in package.Package has correct lot and part number.Received empty bag was measured against the relevant drawing in which it meets specification for bag.The product review supports the complainant¿s description of the complaint condition therefore this is a confirmed compliant.A review of the manufacturing history for this part does not show any indication that an empty package existed in the lot, however the cause of the complaint condition would be determined as operator error in which the operator did not place a product in the package during the processing of this lot.This lot has been sold in its entirety therefore no inventory exists in monument to review for additional empty packages.This is a confirmed complaint, non-conformance (nc) has been initiated.According to the dhr review this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the production of this lot that would contribute to this complaint condition.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 an unknown date, a sealed, empty cortex screw package was received.There was no patient involvement.This report is for one (1) 4.0mm cortex screw.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.0MM CRTX SCR S/TAP 34MM
• 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: 7943277
• Report Number: 2939274-2018-54222
• Device Sequence Number: 10955165
• Product Code: HWC
• UDI-Device Identifier: 10886982147578
• UDI-Public: (01)10886982147578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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
• Report Date (Section B): 06/01/2018

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: 206.434
• Device Catalogue Number: 206.434
• Device Lot Number: H573984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1