MAUDE Adverse Event Report: SYNTHES GMBH SPEED TITAN 20X20X20MM IMPLANT KIT; STAPLE, FIXATION, BONE

Model Number SE-2020TI

Device Problem Break (1069)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

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 synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure the implant holder did not hold the implant.There was a surgical delay of (3) minutes.Another holder was used.There was no impact to the patient.The procedure was completed successfully.This report involves (1) speed titan 20x20x20mm implant kit.This is report 1 of 1 for (b)(4).

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, h4, h6- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot
=
> part # se-2020ti.Synthes lot # mse200055.Supplier lot # mse200055.Release to warehouse date: 25aug2020.Expiration date: 01jul2025.Supplier: (b)(4).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.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 20X20X20MM IMPLANT KIT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12378672
• MDR Text Key: 268524687
• Report Number: 8030965-2021-07293
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021569
• UDI-Public: (01)00810633021569
• Combination Product (y/n): N
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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
• Device Operator: Health Professional
• Device Model Number: SE-2020TI
• Device Catalogue Number: SE-2020TI
• Device Lot Number: MSE200055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/07/2021
• Patient Sequence Number: 1
• Treatment: UNK - HANDLES: TRAUMA; UNK - HANDLES: TRAUMA