MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 110MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.210
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional 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: b3: only the event year is known.H3, h4, h6: 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 sample revealed that tfna fenestrated screw 110mm was observed signs of usage and normal wear the tip threads slightly stripped, which could have been a result of implantation and explantation.No other defect was found.A dimensional inspection for the tfna fenestrated screw 110mm was not performed as it is not applicable to the complaint condition.The observed condition of the device could have been a result of implantation and explantation.The overall complaint was confirmed as the observed condition of the tfna fenestrated screw 110mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part number: 04.038m210sp lot number: 4135p12 part manufacturing date: 25-jan-2023 manufacturing site: elmira a review of the device history record revealed no complaint-related anomalies.The device history record shows lot 4135p12 of tfna fenestrated screws was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot 529p951 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint-related anomalies.This 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.
Event or Problem Description
Device report from synthes reports an event in austria as follows: it was reported that on an unknown date, the patient required a removal of a tfna nail because it had broken.The implant had been in the patient for three to four weeks.The revision was performed because the patient had a femur fracture.Upon inspection of the returned devices on december 15, 2023, it was noted that the ti tfna fenestrated screw and the locking screw were stripped.This report involves one tfna fenestrated screw 110mm.This is report 2 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 110MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18351042
• Report Number: 8030965-2023-15857
• Device Sequence Number: 5600345
• Product Code: HSB
• UDI-Device Identifier: 10886982098801
• UDI-Public: (01)10886982098801
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.210
• Device Lot Number: 4135P12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø9 R 125° L235 TIMO15
• Patient Age: 89 YR
• Patient Sex: Female