MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Catalog Number	02.211.018
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on november 22, 2023, the package that was supposed to contain a screw was delivered sealed and empty.All contents were received but one of the packets.No further information is available.This report involves one 2.7mm va lckng screw slf-tpng with t8 stardrive recess 18mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product codes: hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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.
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 the product was not returned to depuy synthes, however photos were provided for review.The depuy synthes team forwarded the evidence to jabil which conducted a visual inspection.The photo evidence provided revealed that the 2.7mm va lckng screw slf-tpng with t8 stardrive recess 18mm package was labeled, had weak seals but there was no conclusive evidence of a hole being big enough to accommodate a screw.Hence this will be considered as an empty pouch.The complaint condition was confirmed as a non-sterile package with missing product/weak seal.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 confirmed for the 2.7 va lckng scr slf-tpng t8 sd rec 18.The root cause of the complaint condition can be confirmed due to the manufacturing issue.Based on the investigation findings, the root cause is traced to manufacturing.The product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H4, h6 manufacturing location: monument manufacturing date: 25-jul-2023 part number: 02.211.018, 2.7mm va lckng screw slf-tpng with t8 stardrive recess 18mm lot number: 7178p30.Three pieces were scrapped in cell at op #10, mill shaft thread/thread head for set up.Eleven pieces were scrapped in cell at op #50, sputter coating, for coating-sputter coat color.Production order traveler met all inspection acceptance criteria apart from the fourteen pieces noted.Inspection certificate, 02.211.008-us-1-btq905959 /5, met all inspection acceptance criteria.Packaging label log (pll) lmd rev b, and lppf rev d were reviewed and determined to be conforming.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 ¿empty package¿ 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.
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.H6: component code.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: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Common Device Name: SCREW, FIXATION, 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: 18329109
• Report Number: 8030965-2023-15718
• Device Sequence Number: 20712919
• Product Code: HWC
• UDI-Device Identifier: 10886982053602
• UDI-Public: (01)10886982053602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 02.211.018
• Device Lot Number: 7178P30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 06/03/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/19/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown