MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Catalog Number	04.211.016
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from south korea reports an event as follows: it was reported that on 14-july-2023, it was discovered that the screw in question was missing from the package.There was no evidence of the part being opened previously.There was no reported patient or procedure impact.No further information is available.This report is for a 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 16mm.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.H10 additional narrative: d2: additional procode: hrs d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
The event was identified in the local distributor's facility, therefore, no patient was involved with the event.
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: h3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.Manufacturing date: 15 march 2023, part: 04.211.016, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 16mm, lot: 5026p05 (non-sterile).Two pieces were scrapped at turn/thread head, flute, after a robot misload.There was a two-piece undercount recorded at final inspection.Production order traveler met all inspection acceptance criteria apart from the two pieces (misload) noted.Inspection certificate met all inspection acceptance criteria apart from the two pieces noted.Packaging label log (pll) was reviewed and determined to be conforming.A total of 242 labels were printed.236 labels were used on product; 1 label was used on the pll, and 5 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 ¿there was no screw inside the package¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Note: following investigation was performed by the supplier.The product was returned to depuy synthes for evaluation.The depuy synthes team took pictures and forwarded to the supplier which conducted a visual inspection of the returned device.The affected part was not returned to jabil monument.A photograph was provided that displayed the visual evidence.The photo evidence provided revealed that the va lockscr ø2.7 head 2.4 self-tap l16 ta package was labeled on both sides, had no holes or damaged, all seals were intact, and there was no product.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Per the complaint and photo evidence, the complaint condition was confirmed as non-sterile package with missing component va lockscr ø2.7 head 2.4 self-tap l16 ta.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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• 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: 17427247
• Report Number: 8030965-2023-09569
• Device Sequence Number: 5922197
• Product Code: HWC
• UDI-Device Identifier: 10886982119001
• UDI-Public: (01)10886982119001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 04.211.016
• Device Lot Number: 5026P05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/26/2023; 10/12/2023; 11/09/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/12/2023; 11/01/2023; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown