MAUDE Adverse Event Report: SYNTHES GMBH PFNA ø9 130° L240 TAN; NAIL, FIXATION, BONE

Catalog Number 472.401S

Device Problem Migration (4003)

Patient Problems Pain (1994); Limb Fracture (4518)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2023, there was postoperative dislocation of the pfna nail (proximal femoral nail antirotation) without trauma.There was a periprosthetic bone fracture around the nail.Secondary reposition loss in the sense of a nail cut-out after osteosynthesis of pertrochanteric fracture by means of pfna and pain were noted, therefore the wire cages, distal locking screw, and nail were removed on (b)(6) 2023.Implantation of a hybrid hip tep (total endoprosthesis) was performed.This report involves one pfna ã¸9 130â° l240 tan.This report is related to (b)(4), which reports an infection that occurred after the revision to the hip prosthesis.This is report 1 of 3 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.H10 additional narrative: b3: only the event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter phone number reported as: (b)(6).G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: 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.H4: a manufacturing record evaluation was performed for the finished device product code: 472.401s-15, lot no: 6430p96.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on:29-jun-2023, manufacturing site: jabil bettlach, expiry date:01-jun-2033.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: PFNA ø9 130° L240 TAN
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18398013
• MDR Text Key: 331384454
• Report Number: 8030965-2023-16169
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819292864
• UDI-Public: (01)07611819292864
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.401S
• Device Lot Number: 6430P96
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CERCL-CABLE W/CRIMP Ø1.7; LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; PFNA BLADE PERF L115 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female