MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.405S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during a meeting of the aotc held on (b)(6) 2021, slides were presented which represented four tfna cases with medial blade migration into the pelvic area.All four cases were revised to a prosthesis.This captures the case with patient: female, (b)(6) years old at time of event.Patient began to complain of pain on (b)(6) 2021.This report is for a tfna fenestrated helical blade 105mm - sterile.This is report 1 of 1 for (b)(4).Additional reports are captured under (b)(4).

Manufacturer Narrative

Patient height reported as 167cm.Additional procode: ktt.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.

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: d4.H6: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that tfna helical blade perf l105 tan had a nail and screw system is visible at the femur right with signs of fracture, the blade appears to have migrated from original position.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 l105 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.H4, h6: a device history record (dhr) review was conducted: manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: 02-jan-2020.Expiration date: 01-dec-2029.Part number: 04.038.405s, tfna fenestrated helical blade 105mm -sterile.Lot number: 31p9636 (sterile).Lot quantity: (b)(4).Note: helical blade was manufactured by elmira; lot number 30p0804.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that 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.G1: corrected physical manufacturer.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13667095
• MDR Text Key: 286571615
• Report Number: 8030965-2022-01366
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099310
• UDI-Public: (01)10886982099310
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.405S
• Device Catalogue Number: 04.038.405S
• Device Lot Number: 31P9636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0 TI LCKNG SCREW T25 SD 38 F/IM NAIL-S; TFNA FEM NAIL Ø11 130° L200 TIMO15; UNK - END CAPS: TFNA
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 75 KG