MAUDE Adverse Event Report: SYNTHES GMBH SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.224.01C

Device Problem Break (1069)

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

Event Date 12/18/2023

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer.Review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in china as follows: it was reported that there was screw breakage.It was reported that during the surgery , when insert the screw, the screw's was broken, changed another one to continue the surgery and the same problem happened again.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) scr ø1.5 self-drill l4 tan 1u i/clip.This is report 1 of 2 for complaint (b)(4).

Event Description

Surgery was completed successfully with no surgical delay.

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.H4: device history manufacturing location: monument, manufacturing date: 21-apr-2023, part number: 04.503.224.01c, ti matrixmidface screw self- drilling 4mm, lot number: 5726p41 (non-sterile), lot quantity: (b)(4).Three pieces documented as quantity count-under at op #90, final inspection.Production order traveler met all inspection acceptance criteria apart from the three parts noted.Inspection certificate / 1 met all inspection acceptance criteria.Packaging label log 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: part number: 21015, tialnbri4.00, lot number: 4587p80, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) company dated 02-feb-2023 was reviewed and determined to be conforming.Lot summary report dated 13-feb-2023 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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: SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18607060
• MDR Text Key: 334102782
• Report Number: 8030965-2024-01582
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908512
• UDI-Public: (01)07611819908512
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083388
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.224.01C
• Device Lot Number: 5726P41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP