MAUDE Adverse Event Report: SYNTHES GMBH T-PLIF IMPLANT HOLDER; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 389.266

Device Problem Material Integrity Problem (2978)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in canada as follows: the surgeon was inserting a tplif graft from mtf and one of the 'arms' at the proximal tip was significantly bent.The nurse subsequently attempted to straighten the arm and it broke off on the back table.The surgeon was able to complete the case with the other set found at the hospital.Nothing fell into the patient and the patient was not impacted, therefore no patient details were obtained.There was no surgical delay.Fragments were generated and were removed without interventional.No fragments fell into the patient and the piece was thrown away.There were no patient outcome or consequences.This report is for one (1) t-plif implant holder.This is report 1 of 1 for complaint (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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.

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.Investigation summary: photos were provided for review.The photo investigation revealed that the one of the tip end of t-plif implant holder was broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the t-plif implant holder would contribute to the complained device issue.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the t-plif implant holder was broken from the tip.The broken fragment was not returned for evaluation.A dimensional inspection was not performed due to post manufacturing damage.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 t-plif implant holder would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed? reviewed.Device history: part number: 389.266; lot number: t179236; manufacturing site: tuttlingen.Release to warehouse date: 23-jul-2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.,part number: 389.266; lot number: t179236; manufacturing site: tuttlingen.Release to warehouse date: 23-jul-2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: T-PLIF IMPLANT HOLDER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18770334
• MDR Text Key: 337072240
• Report Number: 8030965-2024-02850
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10705034775210
• UDI-Public: (01)10705034775210
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 389.266
• Device Lot Number: T179236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1