MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 100MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.400S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional product code: ktt initial reporter is a synthes sales representative 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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) , 2021, the patient underwent an open reduction internal fixation surgery for trochanteric fracture of femur.After surgery, in (b)(6), 2022, the patient had a rear-end accident while driving.A week after the accident, the patient visited the hospital with a complaint of pain and was examined.As a result, a cut-out was found.On (b)(6), 2022, the revision surgery via tha will be performed.The surgeon commented that this cut-out was likely unrelated to the products and caused by the traffic accident and walking after the accident.No further information is available.This report is for a helical blade.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H4 device history: manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: 02-dec-2019.Expiration date: 01-nov-2029.Part number: 04.038.400s, tfna fenestrated helical blade 100mm -sterile.Lot number: 28p2116 (sterile).Lot quantity: (b)(4).Note: helical blade was manufactured by elmira; lot number 25p7956.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16905 supplied by sterigenics 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.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100MM - 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: 13830583
• MDR Text Key: 287557270
• Report Number: 8030965-2022-01759
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099297
• UDI-Public: (01)10886982099297
• 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,Company Representative
• 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

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.400S
• Device Catalogue Number: 04.038.400S
• Device Lot Number: 28P2116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 LE 125° L235 TIMO15; UNK - END CAPS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention