MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.038.390S

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems Non-union Bone Fracture (2369); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hsb.The subject device is received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.Investigation summary - complaint is confirmed as we are able to confirm complaint description, it's visible that the tfna nail is broken through distal locking hole, based on the received pictures.Furthermore, for a further examination it is necessary for us to receive the implant back.Lot number of the involved screw was not provided and product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, during the revision of non-union with broken proximal femoral nailing system (tfna) nail that was implanted (b)(6) 2020.There was no fall or accident of the patient between first intervention and revision surgery.Right at the start of the revision it has been shown that the tip of the helical blade was broken.Removal of broken nail and partial removal of helical blade was successful.Whereas, tip of the helical blade was not successful.According to the surgeon a prosthesis is not an option because of the initial fracture and a plate is not optimal as well because they wanted to reduce blood loss to a minimum.That is why it has been decided to stay with a less invasive nail again.Patient with multiple myeloma going to have radiotherapy in two weeks and also have heart problem.Surgery was completed successfully with no delay.Concomitant devices reported: unknown locking screw (part# unknown, lot# unknown, quantity 1), unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna fenestrated helical blade 90mm.This is report 2 of 2 for complaint (b)(4).This (b)(4) captures the post op event that reports the broken tfna nail and tfna helical blade and (b)(4) captures the intraop event that reports the broken cannulated stepped drill bit.

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: a1 h3, h6: a product investigation was conducted.Visual inspection: the tfna helical blade perf l90 tan (p/n: 04.038.390, lot number: 58p7459) was received at us cq.Visual inspection of the complaint device showed the distal end had broken off.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal end had broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 04.038m390sp lot number: 58p7459 part manufacture date: 09-jun-2020 manufacturing location: elmira part expiration date: n/a nonconformance noted: n/a dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 90mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped to monument for final packaging.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture 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.D6b.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11692176
• MDR Text Key: 261679646
• Report Number: 8030965-2021-03064
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819652576
• UDI-Public: (01)07611819652576
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.390S
• Device Lot Number: 58P7459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø9 LE 130° L235 TIMO15; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Weight: 52