MAUDE Adverse Event Report: SYNTHES GMBH 2.1MM TI MATRIX SCREW SELF-TAPPING/5MM; PLATE, BONE

Catalog Number	04.511.235.01
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
Additional Manufacturer Narrative
Product complaint (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 an order was received empty for a single screw package 04.511.235.01 there were no patient involvement.This report is for one (1) 2.1mm ti matrix screw self-tapping/5mm.This is report 1 of 1 for complaint (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.H3, h4, h6 photo summary the product was not returned to depuy synthes, however photos were provided for review.The depuy synthes team forwarded photos to manufacturer jabil monument.Note: following investigation was performed by the manufacturer jabil the affected part was not returned to jabil monument.One (1) photograph was provided wich shows the label on the bag.The photo evidence provided revealead that the label on the bag is for part 04.511.253.01, batch 1489p91, qty:1.No screw is seen in the provided photo but no photo of the other side of the bag is provided.Without this view it is unknown if this is an empty pouch.Per the complaint and accompanying photo evidence, the complaint condition is not confirmed as a non-sterile package with a missing screw.There is no conclusive evidence the package is missing a screw based on the photo provided with is the front of the package.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the 2.1mm ti matrix screw self-tapping/5mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history manufacturing date: 09-jul-2020, part number: 04.511.235.01, 2.1 mm ti matrix screw self-tapping/5mm, lot number: 1489p91 (non-sterile), lot quantity: (b)(4).Two pieces were scrapped in cell at op #70, anodize, for an unacceptable color.Three pieces were scrapped in cell at op #80, final inspection; one piece for a chip wrap and two pieces for cross-slot damage.A one-piece undercount was recorded at op #100, bag machine pack/label.Production order traveler met all inspection acceptance criteria apart from the six pieces noted.Inspection sheet, inspect dimensional / final inspection, met all inspection acceptance criteria apart from the three pieces noted at final inspection.Packaging label log (pll) was reviewed and determined to be conforming.A total of 238 labels were printed.(b)(4) labels were used on product; 1 label was used on the pll and 3 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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿received a single screw package empty¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported 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.

• Brand Name: 2.1MM TI MATRIX SCREW SELF-TAPPING/5MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 19336961
• Report Number: 8030965-2024-06359
• Device Sequence Number: 15106847
• Product Code: JEY
• UDI-Device Identifier: 10887587023694
• UDI-Public: (01)10887587023694
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.511.235.01
• Device Lot Number: 1489P91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown