MAUDE Adverse Event Report: SYNTHES GMBH SPEED TITAN 25X20X20MM IMPLANT KIT; STAPLE, FIXATION, BONE

Model Number	SE-2520TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
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.Only event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter address line 1: (b)(6), s/n, (b)(4).Part se-2520ti.Synthes lot mse200034.Supplier lot mse200034.Release to warehouse date september 16, 2020.Supplier millstone medical.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that the speedtitan compression impl kit 25x20x20, p/n: se-2520ti, lot: mse200034, was removed from the packaging.The provided evidence shows the device was cracked across the meddle section.Since the devoice was removed from the packaging a root cause can not be established.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for speedtitan compression impl kit 25x20x20, p/n: se-2520ti, lot: mse200034.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
Device report from synthes reports an event in spain as follows: it was reported that on an unknown date, the insertion tool containing the speedtitan implant was broken despite the packaging being correct and undamaged.The doctor ordered another implant of the same part and lot and the same event was repeated.There was no patient consequence.This report involves one (1) speed titan 25x20x20mm implant kit.This is report 2 of 2 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: 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: SPEED TITAN 25X20X20MM IMPLANT KIT
• Common Device Name: STAPLE, 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: 16768695
• Report Number: 8030965-2023-04898
• Device Sequence Number: 19646421
• Product Code: JDR
• UDI-Device Identifier: 00810633021576
• UDI-Public: 00810633021576
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142292
• 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 Expiration Date: 06/01/2025
• Device Model Number: SE-2520TI
• Device Catalogue Number: SE-2520TI
• Device Lot Number: MSE200034
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown