MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L100 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.400S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/25/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery for trochanteric fracture of femur.On (b)(6) 2022, the sales rep got the information that the patient would undergo a removal surgery of the blade.When the sales rep checked the picture of the patient, it was found that the blade cut through the bone head, the acetabular and was embedded in pelvis.The removal surgery is planned on (b)(6) 2022.In the removal surgery, only the blade will be removed.The sales rep is now checking the details.No further information is available.This report is for one (1) tfna helical blade perf l100 tan.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.H3, h6: part:04.038.400s.Lot: 27p9561.Release to warehouse date: november 14, 2019.Manufacturing site: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo visual analysis of the provided x-ray revealed that the reported tfna helical blade perf l100 tan has migrated towards the acetabulum.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 tfna helical blade perf l100 tan.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.

• Brand Name: TFNA HELICAL BLADE PERF L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13840493
• MDR Text Key: 287544998
• Report Number: 8030965-2022-01787
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652590
• UDI-Public: (01)07611819652590
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400S
• Device Lot Number: 27P9561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 R 125° L340 TIMO15.; UNK - END CAPS: TFNA.; UNK - SCREWS: NAIL DISTAL LOCKING.
• Patient Outcome(s): Required Intervention