MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 28MM; SCREW, FIXATION, BONE

Model Number	214.828
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on unknown date that while restocking the consultant noticed that the set of package for the screw was empty, no damage to the package.It is unknown if there were patient and procedure involvement.This report involves one (1) 4.5mm cortex screw self-tapping 28mm.This is report 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.Device product codes: ktt.Initial reporter is a j&j employee.Manufacturing location: (b)(4).Manufacturing date: 27-dec-2021 part number: 214.828, 4.5mm cortex screw self-tapping 28mm.Lot number: 582p634 (non-sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, mill threads/flute/ final inspection, met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.A total of (b)(4) labels were printed.(b)(4) labels were used on product; (b)(4) label was used on the pll and (b)(4) labels were destroyed.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.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.The product was returned to depuy synthes for evaluation.The depuy synthes provide images to the supplier monument manufacturing facility for investigation.The affected part was not returned.Visual analysis of the photographic evidence revelated that the 4.5mm cortex screw self-tapping 28mm was missing from the sealed packaging.The packaging is sealed with no damage to the packaging.Per: "package and label per bom, lppf, pkda, and ldm as required.Otherwise, per process sheet stated on the product traveler." the ldm, bom, and lppf for device lot number 582p634 require a quantity of 1 part per package.The complaint condition was confirmed as non-sterile package with no parts inside of the require one.Per the complaint and accompanying photographic evidence, the complaint condition was confirmed as a non-sterile package with missing product.The affected part was not returned, and the condition was confirmed based on the photographic provided.A nonconformance, (b)(4), has therefore ben initiated.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 4.5MM CORTEX SCREW SELF-TAPPING 28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14954816
• Report Number: 2939274-2022-02510
• Device Sequence Number: 6953167
• Product Code: HWC
• UDI-Device Identifier: 10886982154637
• UDI-Public: 10886982154637
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 214.828
• Device Catalogue Number: 214.828
• Device Lot Number: 582P634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown