MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA LOCKING SCREW SDDRIVE 10MM; SCREW, FIXATION, BONE

Model Number 04.210.110

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

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.Additional narrative: additional pro-code: hrs complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 Description

Device report from depuy synthes reports an event in india as follows: it was reported that the distributor has found 2 products instead of 1 in single packing pouch.There was no patient involvement.This report is for one (1) 2.4mm ti va locking screw sddrive 10mm this is report 1 of 1 for complaint:(b)(6).

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: manufacturing location: monument; manufacturing date: 11-mar-2022; part number: 04.210.110, 2.4mm ti va locking screw stardrive 10mm; lot number: 703p335 (non-sterile).Production order traveler met all inspection acceptance criteria apart from the thirteen pieces noted.Inspection sheet, mill shaft thread / head thread / flutemet all inspection acceptance criteria apart from the eight pieces (surface finish) noted.Packaging label log (pll) was 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 ¿two products instead of one in single pouch¿ does not indicate breakage of the or any of its components.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.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded photographs of the device to jabil monument where a visual inspection was conducted.The affected part was not returned to jabil monument.Photographic evidence was provided that displayed the complaint condition.The photographic evidence provided revealed that the 2.4mm tl va locking screw stardrive 10mm package contained two pieces, no visible holes or damage were identified, and the seals were intact.Per the complaint and accompanying photographic evidence, the complaint condition was confirmed as a non-sterile package with two pieces in the package.The affected part was not returned to jabil monument, and the condition was confirmed based on the photographic evidence.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 2.4mm ti va locking screw sddrive 10mm, p/n: 04.210.110, lot: 703p335 would contribute to the complained device issue.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.

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 subject 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.

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.Additional narrative: the product was returned to depuy synthes for evaluation.The depuy synthes team forwarded photographs of the device to jabil monument where a visual inspection was conducted.Visual inspection of the photographic evidence was provided revealed that the 2.4mm tl va locking screw stardrive 10mm package contained two pieces, no visible holes or damage were identified, and the seals were intact.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM TI VA LOCKING SCREW SDDRIVE 10MM
• Type of Device: 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: 16755878
• MDR Text Key: 313450945
• Report Number: 8030965-2023-04771
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982118448
• UDI-Public: (01)10886982118448
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.210.110
• Device Catalogue Number: 04.210.110
• Device Lot Number: 703P335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1