MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 28MM; SCREW, FIXATION, BONE

Catalog Number	204.828
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, item 204.828 is missing from the package.The plastic bag for the item is in the package, but the screw was not in the package.Lot number 24200p0 is listed on the package.There was no patient involvement.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 history review (dhr): manufacturing location: monument.Manufacturing date: 18-jun-2024.Part number: 204.828, 3.5mm cortex screw self-tapping 28mm.Lot number: 24200p0 (non-sterile).Lot quantity: 240.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿product missing from its packaging¿ 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 20236056
• Report Number: 8030965-2024-11607
• Device Sequence Number: 18271896
• Product Code: HWC
• UDI-Device Identifier: 10886982146328
• UDI-Public: (01)10886982146328(10)24200PO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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 Catalogue Number: 204.828
• Device Lot Number: 24200P0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown